The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8mm And 10mm.
| Device ID | K060704 |
| 510k Number | K060704 |
| Device Name: | ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, SIZES 8MM AND 10MM |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Dalene T Binkley |
| Correspondent | Dalene T Binkley 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-16 |
| Decision Date | 2006-05-19 |
| Summary: | summary |