Smith & Nephew, Inc., Orthopaedic Div. · Class II · Cleared Jan 2, 1997
| K-number | K963255 |
| Device name | PROFIX PLUS TIBIAL INSERT, PROFIX PS PLUS TIBIAL INSERT, PROFIX P/S TIBIAL INSERT |
| Applicant | Smith & Nephew, Inc., Orthopaedic Div. |
| Product code | JWH |
| Device class | Class II |
| Decision date | Jan 2, 1997 |
| Decision | Substantially Equivalent for Some Indications |
| Regulation | 888.3560 |
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