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 |