PROFIX CONFORMING PLUS TIBIAL INSERT— 510(k) K946236
Substantially EquivalentSmith & Nephew Richards, Inc.
FDA 510(k) clearance K946236 for PROFIX CONFORMING PLUS TIBIAL INSERT, Substantially Equivalent on 1995-07-06. Applicant: Smith & Nephew Richards, Inc.. Device class: 2.
Clearance details
- Applicant
- Smith & Nephew Richards, Inc.
- Product code
- Code KWH
- Device class
- Class 2
- Regulation
- 21 CFR 888.3720
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Memphis, TN, US
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