The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Darwin Knee System (cruciate Substituting) Porous Coated And Non-porous Coated.
| Device ID | K950010 |
| 510k Number | K950010 |
| Device Name: | DARWIN KNEE SYSTEM (CRUCIATE SUBSTITUTING) POROUS COATED AND NON-POROUS COATED |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. ROUTE 202 N. Raritan, NJ 08869 |
| Contact | John D Ferros |
| Correspondent | John D Ferros JOHNSON & JOHNSON PROFESSIONALS, INC. ROUTE 202 N. Raritan, NJ 08869 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-03 |
| Decision Date | 1995-05-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295232599 | K950010 | 000 |
| 10603295232223 | K950010 | 000 |
| 10603295152484 | K950010 | 000 |
| 10603295152477 | K950010 | 000 |
| 10603295152453 | K950010 | 000 |
| 10603295152446 | K950010 | 000 |
| 10603295152439 | K950010 | 000 |
| 10603295152422 | K950010 | 000 |
| 10603295152415 | K950010 | 000 |
| 10603295152408 | K950010 | 000 |
| 10603295152392 | K950010 | 000 |
| 10603295152385 | K950010 | 000 |
| 10603295152378 | K950010 | 000 |
| 10603295232230 | K950010 | 000 |
| 10603295232247 | K950010 | 000 |
| 10603295232537 | K950010 | 000 |
| 10603295232445 | K950010 | 000 |
| 10603295232421 | K950010 | 000 |
| 10603295232414 | K950010 | 000 |
| 10603295232407 | K950010 | 000 |
| 10603295232384 | K950010 | 000 |
| 10603295232360 | K950010 | 000 |
| 10603295232346 | K950010 | 000 |
| 10603295232308 | K950010 | 000 |
| 10603295232285 | K950010 | 000 |
| 10603295232261 | K950010 | 000 |
| 10603295232254 | K950010 | 000 |
| 10603295152460 | K950010 | 000 |