The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Straight Wrist Fusion Plate, 170mm.
| Device ID | K011458 |
| 510k Number | K011458 |
| Device Name: | SYNTHES STRAIGHT WRIST FUSION PLATE, 170MM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Single Component |
| Applicant | SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Contact | Matthew M Hull |
| Correspondent | Matthew M Hull SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Product Code | KTW |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-11 |
| Decision Date | 2001-08-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679SD4420020 | K011458 | 000 |
| H679SD2420020 | K011458 | 000 |