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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: AperFix® Tibial Implant 8mmx30mm - CM-3008; AperFix®II Cannulated Tibial 10mmx30mm - CM-3010C; AperFix®II Cannulated Tibial 11mmx30mm - CM-3011C; AperFix®II Cannulated Tibial 9mmx30mm - CM-3009C
Classification Name: SCREW, FIXATION, BONE
Product Code: HWC
Device Class: 2
Regulation Number: 888.3040
Medical Specialty: Orthopedic
Registered Establishment Name: CAYENNE MEDICAL, INC.
Registered Establishment Number: 3006108336
Premarket Submission Number: K083607
Owner/Operator: CAYENNE MEDICAL, INC.
Owner/Operator Number: 9091610
Establishment Operations: Manufacturer
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