The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) 2.4 Mm Lcp Wrist Plate.
| Device ID | K040588 |
| 510k Number | K040588 |
| Device Name: | SYNTHES (USA) 2.4 MM LCP WRIST PLATE |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Contact | Lisa M Boyle |
| Correspondent | Lisa M Boyle SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-05 |
| Decision Date | 2004-05-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679SD2420030 | K040588 | 000 |