The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer Trabecular Metal Reverse Shoulder System, Base Plates & Humeral Stems.
| Device ID | K121543 |
| 510k Number | K121543 |
| Device Name: | ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, BASE PLATES & HUMERAL STEMS |
| Classification | Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Anthony Francalancia |
| Correspondent | Anthony Francalancia ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | KWT |
| Subsequent Product Code | HSD |
| Subsequent Product Code | KWS |
| Subsequent Product Code | PHX |
| CFR Regulation Number | 888.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-25 |
| Decision Date | 2012-10-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024435520 | K121543 | 000 |
| 00889024267534 | K121543 | 000 |
| 00889024267275 | K121543 | 000 |
| 00889024267268 | K121543 | 000 |
| 00889024267183 | K121543 | 000 |
| 00889024267176 | K121543 | 000 |
| 00889024209145 | K121543 | 000 |
| 00889024504479 | K121543 | 000 |
| 00889024460027 | K121543 | 000 |
| 00889024405585 | K121543 | 000 |
| 00889024405578 | K121543 | 000 |
| 00889024405561 | K121543 | 000 |
| 00889024405554 | K121543 | 000 |
| 00889024405547 | K121543 | 000 |
| 00889024405530 | K121543 | 000 |
| 00889024274310 | K121543 | 000 |
| 00889024274303 | K121543 | 000 |
| 00889024274297 | K121543 | 000 |
| 00889024267565 | K121543 | 000 |
| 00889024267572 | K121543 | 000 |
| 00889024269040 | K121543 | 000 |
| 00889024269033 | K121543 | 000 |
| 00889024269026 | K121543 | 000 |
| 00889024269019 | K121543 | 000 |
| 00889024269002 | K121543 | 000 |
| 00889024268999 | K121543 | 000 |
| 00889024268982 | K121543 | 000 |
| 00889024268456 | K121543 | 000 |
| 00889024268388 | K121543 | 000 |
| 00889024267831 | K121543 | 000 |
| 00889024267824 | K121543 | 000 |
| 00889024267701 | K121543 | 000 |
| 00889024267688 | K121543 | 000 |
| 00889024267664 | K121543 | 000 |
| 00889024267657 | K121543 | 000 |
| 00889024267640 | K121543 | 000 |
| 00889024267602 | K121543 | 000 |
| 00889024274273 | K121543 | 000 |