The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer Trabecular Metal Reverse Shoulder System, Non-porous Humeral Stems.
| Device ID | K122692 |
| 510k Number | K122692 |
| Device Name: | ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, NON-POROUS HUMERAL STEMS |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| 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 | PHX |
| Subsequent Product Code | HSD |
| Subsequent Product Code | KWS |
| Subsequent Product Code | KWT |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-04 |
| Decision Date | 2012-12-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024209152 | K122692 | 000 |
| 00889024268173 | K122692 | 000 |
| 00889024268203 | K122692 | 000 |
| 00889024268234 | K122692 | 000 |
| 00889024268258 | K122692 | 000 |
| 00889024268289 | K122692 | 000 |
| 00889024268319 | K122692 | 000 |
| 00889024268333 | K122692 | 000 |
| 00889024268364 | K122692 | 000 |
| 00889024268159 | K122692 | 000 |
| 00889024268128 | K122692 | 000 |
| 00889024266896 | K122692 | 000 |
| 00889024267206 | K122692 | 000 |
| 00889024267213 | K122692 | 000 |
| 00889024267374 | K122692 | 000 |
| 00889024267381 | K122692 | 000 |
| 00889024268043 | K122692 | 000 |
| 00889024268074 | K122692 | 000 |
| 00889024268098 | K122692 | 000 |
| 00889024268395 | K122692 | 000 |
| 00889024268418 | K122692 | 000 |
| 00889024269231 | K122692 | 000 |
| 00889024269347 | K122692 | 000 |
| 00889024269354 | K122692 | 000 |
| 00889024269361 | K122692 | 000 |
| 00889024269378 | K122692 | 000 |
| 00889024269385 | K122692 | 000 |
| 00889024405592 | K122692 | 000 |
| 00889024405608 | K122692 | 000 |
| 00889024435551 | K122692 | 000 |
| 00889024269330 | K122692 | 000 |
| 00889024269323 | K122692 | 000 |
| 00889024269248 | K122692 | 000 |
| 00889024269255 | K122692 | 000 |
| 00889024269262 | K122692 | 000 |
| 00889024269279 | K122692 | 000 |
| 00889024269286 | K122692 | 000 |
| 00889024269293 | K122692 | 000 |
| 00889024269309 | K122692 | 000 |
| 00889024269316 | K122692 | 000 |
| 00889024435568 | K122692 | 000 |