PATIENT MATCHED COBALT ALLOY TROCHLEA REPLACEMENT— 510(k) K001374
Substantially EquivalentBiomet Manufacturing, Inc.
FDA 510(k) clearance K001374 for PATIENT MATCHED COBALT ALLOY TROCHLEA REPLACEMENT, Substantially Equivalent on 2000-07-27. Applicant: Biomet Manufacturing, Inc.. Device class: 2.
Clearance details
- Applicant
- Biomet Manufacturing, Inc.
- Product code
- Code KRR
- Device class
- Class 2
- Regulation
- 21 CFR 888.3540
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Warsaw, IN, US
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