The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Trochanter Stabilization Plate For Dhs.
| Device ID | K000972 |
| 510k Number | K000972 |
| Device Name: | SYNTHES (USA) TROCHANTER STABILIZATION PLATE FOR DHS |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite |
| 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 | LXT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-27 |
| Decision Date | 2000-06-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679281870S0 | K000972 | 000 |
| H6792818700 | K000972 | 000 |