The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer M/l Taper Hip Prosthesis.
| Device ID | K192660 |
| 510k Number | K192660 |
| Device Name: | Zimmer M/L Taper Hip Prosthesis |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | Zimmer, Inc. 1800 W. Center Street Warsaw, IN 46580 |
| Contact | Caleb Barylski |
| Correspondent | Caleb Barylski Zimmer, Inc. 1800 W. Center Street Warsaw, IN 46580 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-25 |
| Decision Date | 2020-02-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024132283 | K192660 | 000 |
| 00889024132047 | K192660 | 000 |
| 00889024132061 | K192660 | 000 |
| 00889024132085 | K192660 | 000 |
| 00889024132108 | K192660 | 000 |
| 00889024132122 | K192660 | 000 |
| 00889024132146 | K192660 | 000 |
| 00889024132160 | K192660 | 000 |
| 00889024132184 | K192660 | 000 |
| 00889024132207 | K192660 | 000 |
| 00889024132221 | K192660 | 000 |
| 00889024132245 | K192660 | 000 |
| 00889024132269 | K192660 | 000 |
| 00889024132023 | K192660 | 000 |