The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Next Generation Knee System.
| Device ID | K933785 |
| 510k Number | K933785 |
| Device Name: | NEXT GENERATION KNEE SYSTEM |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Ruth Ann Wood |
| Correspondent | Ruth Ann Wood ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| 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 | 1993-08-04 |
| Decision Date | 1995-01-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024215481 | K933785 | 000 |
| 00889024215351 | K933785 | 000 |
| 00889024215344 | K933785 | 000 |
| 00889024215337 | K933785 | 000 |
| 00889024215320 | K933785 | 000 |
| 00889024215313 | K933785 | 000 |
| 00889024215306 | K933785 | 000 |
| 00889024215290 | K933785 | 000 |
| 00889024215283 | K933785 | 000 |
| 00889024215276 | K933785 | 000 |
| 00889024215269 | K933785 | 000 |
| 00889024215368 | K933785 | 000 |
| 00889024215375 | K933785 | 000 |
| 00889024215474 | K933785 | 000 |
| 00889024215467 | K933785 | 000 |
| 00889024215450 | K933785 | 000 |
| 00889024215443 | K933785 | 000 |
| 00889024215436 | K933785 | 000 |
| 00889024215429 | K933785 | 000 |
| 00889024215412 | K933785 | 000 |
| 00889024215405 | K933785 | 000 |
| 00889024215399 | K933785 | 000 |
| 00889024215382 | K933785 | 000 |
| 00889024215252 | K933785 | 000 |