The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Modification To Synthes (usa) Trochanter Stabilization Plate (tsb) For Dhs (line Extension).
| Device ID | K002710 |
| 510k Number | K002710 |
| Device Name: | MODIFICATION TO SYNTHES (USA) TROCHANTER STABILIZATION PLATE (TSB) FOR DHS (LINE EXTENSION) |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Bonnie J Smith |
| Correspondent | Bonnie J Smith SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-31 |
| Decision Date | 2000-09-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679281869S0 | K002710 | 000 |
| H6792818690 | K002710 | 000 |