The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Cruciate Retaining (augmentable) And Constrained Condylar Knee (cck).
| Device ID | K946150 |
| 510k Number | K946150 |
| Device Name: | CRUCIATE RETAINING (AUGMENTABLE) AND CONSTRAINED CONDYLAR KNEE (CCK) |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Ruth A Wood |
| Correspondent | Ruth A 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 | 1994-12-16 |
| Decision Date | 1995-07-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024224148 | K946150 | 000 |
| 00889024224087 | K946150 | 000 |
| 00889024224032 | K946150 | 000 |
| 00889024224018 | K946150 | 000 |
| 00889024223981 | K946150 | 000 |
| 00889024223943 | K946150 | 000 |