The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zca All-poly Acetabular Cups.
| Device ID | K191449 |
| 510k Number | K191449 |
| Device Name: | ZCA All-Poly Acetabular Cups |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| 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 | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-31 |
| Decision Date | 2020-07-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024362314 | K191449 | 000 |
| 00889024144361 | K191449 | 000 |
| 00889024144354 | K191449 | 000 |
| 00889024144347 | K191449 | 000 |
| 00889024638631 | K191449 | 000 |
| 00889024638624 | K191449 | 000 |
| 00889024638617 | K191449 | 000 |
| 00889024638600 | K191449 | 000 |
| 00889024638594 | K191449 | 000 |
| 00889024638587 | K191449 | 000 |
| 00889024638570 | K191449 | 000 |
| 00889024638563 | K191449 | 000 |
| 00889024638556 | K191449 | 000 |
| 00889024144378 | K191449 | 000 |
| 00889024144385 | K191449 | 000 |
| 00889024362307 | K191449 | 000 |
| 00889024362291 | K191449 | 000 |
| 00889024362284 | K191449 | 000 |
| 00889024362277 | K191449 | 000 |
| 00889024362260 | K191449 | 000 |
| 00889024362253 | K191449 | 000 |
| 00889024362246 | K191449 | 000 |
| 00889024362239 | K191449 | 000 |
| 00889024362222 | K191449 | 000 |
| 00889024144415 | K191449 | 000 |
| 00889024144408 | K191449 | 000 |
| 00889024144392 | K191449 | 000 |
| 00889024638549 | K191449 | 000 |