The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Miami, Protrusio Ring.
| Device ID | K812182 |
| 510k Number | K812182 |
| Device Name: | MIAMI, PROTRUSIO RING |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | ZIMMER, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-08-03 |
| Decision Date | 1981-08-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024144309 | K812182 | 000 |
| 00889024144187 | K812182 | 000 |
| 00889024144194 | K812182 | 000 |
| 00889024144200 | K812182 | 000 |
| 00889024144217 | K812182 | 000 |
| 00889024144224 | K812182 | 000 |
| 00889024144231 | K812182 | 000 |
| 00889024144248 | K812182 | 000 |
| 00889024144255 | K812182 | 000 |
| 00889024144262 | K812182 | 000 |
| 00889024144279 | K812182 | 000 |
| 00889024144286 | K812182 | 000 |
| 00889024144293 | K812182 | 000 |
| 00889024144170 | K812182 | 000 |