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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Unicondylar Interpostitional Spacer
Classification Name: PROSTHESIS, KNEE, HEMI-, TIBIAL, RESURFACING (UNCEMENTED)
Product Code: HSH
Device Class: 2
Regulation Number: 888.3590
Medical Specialty: Orthopedic
Registered Establishment Name: ZIMMER, INC.
Registered Establishment Number: 1822565
Premarket Submission Number: K003269
Owner/Operator: ZIMMER, INC.
Owner/Operator Number: 1822565
Establishment Operations: Manufacturer
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