The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Reunion Tsa System-humeral Press-fit & Cemented Stems Model 5569-yy-20xx (yy=p,c; Xx=07-17,06l-12l) Reunion Tsa System N.
| Device ID | K103835 |
| 510k Number | K103835 |
| Device Name: | REUNION TSA SYSTEM-HUMERAL PRESS-FIT & CEMENTED STEMS MODEL 5569-YY-20XX (YY=P,C; XX=07-17,06L-12L) REUNION TSA SYSTEM N |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Contact | Avital Merl-margulies |
| Correspondent | Avital Merl-margulies HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-30 |
| Decision Date | 2011-05-05 |
| Summary: | summary |