The following data is part of a premarket notification filed by Zimmer Inc. with the FDA for Alliance Augmented Glenoid.
| Device ID | K193180 |
| 510k Number | K193180 |
| Device Name: | Alliance Augmented Glenoid |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | Zimmer Inc. P.O. Box 708 Warsaw, IN 46581 -0708 |
| Contact | Patricia Sandborn Beres |
| Correspondent | Patricia Sandborn Beres Zimmer Inc. P.O. Box 708 Warsaw, IN 46581 -0708 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-18 |
| Decision Date | 2020-02-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024575325 | K193180 | 000 |
| 00889024574472 | K193180 | 000 |
| 00889024574465 | K193180 | 000 |
| 00889024574458 | K193180 | 000 |
| 00889024574441 | K193180 | 000 |
| 00889024574434 | K193180 | 000 |
| 00889024574427 | K193180 | 000 |
| 00889024574410 | K193180 | 000 |
| 00889024574403 | K193180 | 000 |
| 00889024626171 | K193180 | 000 |
| 00889024626164 | K193180 | 000 |
| 00889024644878 | K193180 | 000 |
| 00889024644861 | K193180 | 000 |
| 00889024644854 | K193180 | 000 |
| 00889024644847 | K193180 | 000 |
| 00889024644830 | K193180 | 000 |
| 00889024644823 | K193180 | 000 |
| 00889024644816 | K193180 | 000 |
| 00889024574601 | K193180 | 000 |
| 00889024574618 | K193180 | 000 |
| 00889024575318 | K193180 | 000 |
| 00889024575301 | K193180 | 000 |
| 00889024575295 | K193180 | 000 |
| 00889024575240 | K193180 | 000 |
| 00889024575233 | K193180 | 000 |
| 00889024575226 | K193180 | 000 |
| 00889024575219 | K193180 | 000 |
| 00889024575202 | K193180 | 000 |
| 00889024575196 | K193180 | 000 |
| 00889024575189 | K193180 | 000 |
| 00889024575172 | K193180 | 000 |
| 00889024575165 | K193180 | 000 |
| 00889024575158 | K193180 | 000 |
| 00889024575141 | K193180 | 000 |
| 00889024575134 | K193180 | 000 |
| 00889024575127 | K193180 | 000 |
| 00889024575110 | K193180 | 000 |
| 00889024644809 | K193180 | 000 |