The following data is part of a premarket notification filed by Symmetry Medical Manufacturing Inc. Dba Tecomet, Inc. with the FDA for Tecomet Global Unite Short Stem Instrumentation.
| Device ID | K211553 |
| 510k Number | K211553 |
| Device Name: | Tecomet Global Unite Short Stem Instrumentation |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | Symmetry Medical Manufacturing Inc. DBA Tecomet, Inc. 3724 North State Road 15 Warsaw, IN 46582 |
| Contact | Mike Parrish |
| Correspondent | David Furr FDC Services LLC 8708 Capehart Cove Austin, TX 78733 |
| Product Code | PHX |
| Subsequent Product Code | HSD |
| Subsequent Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-19 |
| Decision Date | 2021-08-04 |