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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: ATTUNE Revision CRS Rotating Platform Insert Size 3 10 mm; ATTUNE Revision CRS Rotating Platform Insert Size 3 12 mm; ATTUNE Revision CRS Rotating Platform Insert Size 3 14 mm; ATTUNE Revision CRS Rotating Platform Insert Size 3 16 mm; ATTUNE Revision CRS Rotating Platform Insert Size 3 18 mm; ATTUNE Revision CRS Rotating Platform Insert Size 3 20 mm; ATTUNE Revision CRS Rotating Platform Insert Size 3 22 mm; ATTUNE Revision CRS Rotating Platform Insert Size 3 24 mm; ATTUNE Revision CRS Rotating Platform Insert Size 3 26 mm; ATTUNE Revision CRS Rotating Platform Insert Size 3 6 mm; ATTUNE Revision CRS Rotating Platform Insert Size 3 8 mm; ATTUNE Revision CRS Rotating Platform Insert Size 4 10 mm; ATTUNE Revision CRS Rotating Platform Insert Size 4 12 mm; ATTUNE Revision CRS Rotating Platform Insert Size 4 14 mm; ATTUNE Revision CRS Rotating Platform Insert Size 4 16 mm; ATTUNE Revision CRS Rotating Platform Insert Size 4 18 mm; ATTUNE Revision CRS Rotating Platform Insert Size 4 20 mm; ATTUNE Revision CRS Rotating Platform Insert Size 4 22 mm; ATTUNE Revision CRS Rotating Platform Insert Size 4 24 mm; ATTUNE Revision CRS Rotating Platform Insert Size 4 26 mm; ATTUNE Revision CRS Rotating Platform Insert Size 4 6 mm; ATTUNE Revision CRS Rotating Platform Insert Size 4 8 mm; ATTUNE Revision CRS Rotating Platform Insert Size 5 10 mm; ATTUNE Revision CRS Rotating Platform Insert Size 5 12 mm; ATTUNE Revision CRS Rotating Platform Insert Size 5 14 mm; ATTUNE Revision CRS Rotating Platform Insert Size 5 16 mm; ATTUNE Revision CRS Rotating Platform Insert Size 5 18 mm; ATTUNE Revision CRS Rotating Platform Insert Size 5 20 mm; ATTUNE Revision CRS Rotating Platform Insert Size 5 22 mm; ATTUNE Revision CRS Rotating Platform Insert Size 5 24 mm; ATTUNE Revision CRS Rotating Platform Insert Size 5 26 mm; ATTUNE Revision CRS Rotating Platform Insert Size 5 6 mm; ATTUNE Revision CRS Rotating Platform Insert Size 5 8 mm; ATTUNE Revision CRS Rotating Platform Insert Size 6 10 mm; ATTUNE Revision CRS Rotating Platform Insert Size 6 12 mm; ATTUNE Revision CRS Rotating Platform Insert Size 6 14 mm; ATTUNE Revision CRS Rotating Platform Insert Size 6 16 mm; ATTUNE Revision CRS Rotating Platform Insert Size 6 18 mm; ATTUNE Revision CRS Rotating Platform Insert Size 6 20 mm; ATTUNE Revision CRS Rotating Platform Insert Size 6 22 mm; ATTUNE Revision CRS Rotating Platform Insert Size 6 24 mm; ATTUNE Revision CRS Rotating Platform Insert Size 6 26 mm; ATTUNE Revision CRS Rotating Platform Insert Size 6 6 mm; ATTUNE Revision CRS Rotating Platform Insert Size 6 8 mm; ATTUNE Revision CRS Rotating Platform Insert Size 7 10 mm; ATTUNE Revision CRS Rotating Platform Insert Size 7 12 mm; ATTUNE Revision CRS Rotating Platform Insert Size 7 14 mm; ATTUNE Revision CRS Rotating Platform Insert Size 7 16 mm; ATTUNE Revision CRS Rotating Platform Insert Size 7 18 mm; ATTUNE Revision CRS Rotating Platform Insert Size 7 20 mm; ATTUNE Revision CRS Rotating Platform Insert Size 7 22 mm; ATTUNE Revision CRS Rotating Platform Insert Size 7 24 mm; ATTUNE Revision CRS Rotating Platform Insert Size 7 26 mm; ATTUNE Revision CRS Rotating Platform Insert Size 7 6 mm; ATTUNE Revision CRS Rotating Platform Insert Size 7 8 mm; ATTUNE Revision CRS Rotating Platform Insert Size 8 10 mm; ATTUNE Revision CRS Rotating Platform Insert Size 8 12 mm; ATTUNE Revision CRS Rotating Platform Insert Size 8 14 mm; ATTUNE Revision CRS Rotating Platform Insert Size 8 16 mm; ATTUNE Revision CRS Rotating Platform Insert Size 8 18 mm; ATTUNE Revision CRS Rotating Platform Insert Size 8 20 mm; ATTUNE Revision CRS Rotating Platform Insert Size 8 22 mm; ATTUNE Revision CRS Rotating Platform Insert Size 8 24 mm; ATTUNE Revision CRS Rotating Platform Insert Size 8 26 mm; ATTUNE Revision CRS Rotating Platform Insert Size 8 6 mm; ATTUNE Revision CRS Rotating Platform Insert Size 8 8 mm; ATTUNE REVISION RP BASE TRIAL SIZE 10; ATTUNE REVISION RP BASE TRIAL SIZE 2; ATTUNE REVISION RP BASE TRIAL SIZE 3; ATTUNE REVISION RP BASE TRIAL SIZE 4; ATTUNE REVISION RP BASE TRIAL SIZE 5; ATTUNE REVISION RP BASE TRIAL SIZE 6; ATTUNE REVISION RP BASE TRIAL SIZE 7; ATTUNE REVISION RP BASE TRIAL SIZE 8; ATTUNE REVISION RP BASE TRIAL SIZE 9; ATTUNE REVISION RP INSERT TRIAL SIZE 3 10MM; ATTUNE REVISION RP INSERT TRIAL SIZE 3 12MM; ATTUNE REVISION RP INSERT TRIAL SIZE 3 14MM; ATTUNE REVISION RP INSERT TRIAL SIZE 3 16MM; ATTUNE REVISION RP INSERT TRIAL SIZE 3 18MM; ATTUNE REVISION RP INSERT TRIAL SIZE 3 20MM; ATTUNE REVISION RP INSERT TRIAL SIZE 3 22MM; ATTUNE REVISION RP INSERT TRIAL SIZE 3 24MM; ATTUNE REVISION RP INSERT TRIAL SIZE 3 26MM; ATTUNE REVISION RP INSERT TRIAL SIZE 3 6MM; ATTUNE REVISION RP INSERT TRIAL SIZE 3 8MM; ATTUNE REVISION RP INSERT TRIAL SIZE 4 10MM; ATTUNE REVISION RP INSERT TRIAL SIZE 4 12MM; ATTUNE REVISION RP INSERT TRIAL SIZE 4 14MM; ATTUNE REVISION RP INSERT TRIAL SIZE 4 16MM; ATTUNE REVISION RP INSERT TRIAL SIZE 4 18MM; ATTUNE REVISION RP INSERT TRIAL SIZE 4 20MM; ATTUNE REVISION RP INSERT TRIAL SIZE 4 22MM; ATTUNE REVISION RP INSERT TRIAL SIZE 4 24MM; ATTUNE REVISION RP INSERT TRIAL SIZE 4 26MM; ATTUNE REVISION RP INSERT TRIAL SIZE 4 6MM; ATTUNE REVISION RP INSERT TRIAL SIZE 4 8MM; ATTUNE REVISION RP INSERT TRIAL SIZE 5 10MM; ATTUNE REVISION RP INSERT TRIAL SIZE 5 12MM; ATTUNE REVISION RP INSERT TRIAL SIZE 5 14MM; ATTUNE REVISION RP INSERT TRIAL SIZE 5 16MM; ATTUNE REVISION RP INSERT TRIAL SIZE 5 18MM; ATTUNE REVISION RP INSERT TRIAL SIZE 5 20MM; ATTUNE REVISION RP INSERT TRIAL SIZE 5 24MM; ATTUNE REVISION RP INSERT TRIAL SIZE 5 26MM; ATTUNE REVISION RP INSERT TRIAL SIZE 5 6MM; ATTUNE REVISION RP INSERT TRIAL SIZE 5 8MM; ATTUNE REVISION RP INSERT TRIAL SIZE 6 10MM; ATTUNE REVISION RP INSERT TRIAL SIZE 6 12MM; ATTUNE REVISION RP INSERT TRIAL SIZE 6 14MM; ATTUNE REVISION RP INSERT TRIAL SIZE 6 16MM; ATTUNE REVISION RP INSERT TRIAL SIZE 6 18MM; ATTUNE REVISION RP INSERT TRIAL SIZE 6 20MM; ATTUNE REVISION RP INSERT TRIAL SIZE 6 22MM; ATTUNE REVISION RP INSERT TRIAL SIZE 6 24MM; ATTUNE REVISION RP INSERT TRIAL SIZE 6 26MM; ATTUNE REVISION RP INSERT TRIAL SIZE 6 6MM; ATTUNE REVISION RP INSERT TRIAL SIZE 6 8MM; ATTUNE REVISION RP INSERT TRIAL SIZE 7 10MM; ATTUNE REVISION RP INSERT TRIAL SIZE 7 12MM; ATTUNE REVISION RP INSERT TRIAL SIZE 7 14MM; ATTUNE REVISION RP INSERT TRIAL SIZE 7 16MM; ATTUNE REVISION RP INSERT TRIAL SIZE 7 18MM; ATTUNE REVISION RP INSERT TRIAL SIZE 7 20MM; ATTUNE REVISION RP INSERT TRIAL SIZE 7 22MM; ATTUNE REVISION RP INSERT TRIAL SIZE 7 24MM; ATTUNE REVISION RP INSERT TRIAL SIZE 7 26MM; ATTUNE REVISION RP INSERT TRIAL SIZE 7 6MM; ATTUNE REVISION RP INSERT TRIAL SIZE 7 8MM; ATTUNE REVISION RP INSERT TRIAL SIZE 8 10MM; ATTUNE REVISION RP INSERT TRIAL SIZE 8 12MM; ATTUNE REVISION RP INSERT TRIAL SIZE 8 14MM; ATTUNE REVISION RP INSERT TRIAL SIZE 8 16MM; ATTUNE REVISION RP INSERT TRIAL SIZE 8 18MM; ATTUNE REVISION RP INSERT TRIAL SIZE 8 20MM; ATTUNE REVISION RP INSERT TRIAL SIZE 8 22MM; ATTUNE REVISION RP INSERT TRIAL SIZE 8 24MM; ATTUNE REVISION RP INSERT TRIAL SIZE 8 26MM; ATTUNE REVISION RP INSERT TRIAL SIZE 8 6MM; ATTUNE REVISION RP INSERT TRIAL SIZE 8 8MM; ATTUNE REVISION RP STEM ADAPTOR TRIAL; ATTUNE Revision Tibial Base Rotating Platform Size 10 Cemented; ATTUNE Revision Tibial Base Rotating Platform Size 2 Cemented; ATTUNE Revision Tibial Base Rotating Platform Size 3 Cemented; ATTUNE Revision Tibial Base Rotating Platform Size 4 Cemented; ATTUNE Revision Tibial Base Rotating Platform Size 5 Cemented; ATTUNE Revision Tibial Base Rotating Platform Size 6 Cemented; ATTUNE Revision Tibial Base Rotating Platform Size 7 Cemented; ATTUNE Revision Tibial Base Rotating Platform Size 8 Cemented; ATTUNE Revision Tibial Base Rotating Platform Size 9 Cemented; ATTUNE Revision Tibial Sleeve 29 mm Cemented; ATTUNE Revision Tibial Sleeve Porocoat Fully Coated 29 mm; ATTUNE Revision Tibial Sleeve Porocoat Fully Coated 37 mm; ATTUNE Revision Tibial Sleeve Porocoat Fully Coated 45 mm; ATTUNE Revision Tibial Sleeve Porocoat Fully Coated 53 mm; ATTUNE Revision Tibial Sleeve Porocoat Fully Coated 61 mm; ATTUNE Revision Tibial Sleeve Porocoat Fully Coated 69 mm; ATTUNE Revision Tibial Sleeve Porocoat Partially Coated 29 mm; ATTUNE Revision Tibial Sleeve Porocoat Partially Coated 37 mm; ATTUNE Revision Tibial Sleeve Porocoat Partially Coated 45 mm; ATTUNE Revision Tibial Sleeve Porocoat Partially Coated 53 mm; ATTUNE Revision Tibial Sleeve Porocoat Partially Coated 61 mm; ATTUNE Revision Tibial Sleeve Porocoat Partially Coated 69 mm; ATTUNE REVISION TIBIAL SLEEVE TRIAL 29MM; ATTUNE REVISION TIBIAL SLEEVE TRIAL 37MM; ATTUNE REVISION TIBIAL SLEEVE TRIAL 45MM; ATTUNE REVISION TIBIAL SLEEVE TRIAL 53MM; ATTUNE REVISION TIBIAL SLEEVE TRIAL 61MM; ATTUNE REVISION TIBIAL SLEEVE TRIAL 69MM; ATTUNE® Revision Knee System; LCS, New Jersey Total Knee; TRUMATCH Personalized Solutions
Classification Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING
Product Code: NJL
Device Class: 3
Registered Establishment Name: DEPUY ORTHOPAEDICS
Registered Establishment Number: 3004464325
Premarket Submission Number: P830055
Owner/Operator: DePuy Synthes, Inc.
Owner/Operator Number: 1818910
Establishment Operations: Repackager/Relabeler
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