The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Lcp Wrist Fusion Plates.
| Device ID | K042355 |
| 510k Number | K042355 |
| Device Name: | SYNTHES (USA) LCP WRIST FUSION PLATES |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Sheri L Musgnung |
| Correspondent | Sheri L Musgnung SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-31 |
| Decision Date | 2004-10-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H67902110152S0 | K042355 | 000 |
| H67904110150S0 | K042355 | 000 |
| H679041101510 | K042355 | 000 |
| H67904110151S0 | K042355 | 000 |
| H679041101520 | K042355 | 000 |
| H67904110152S0 | K042355 | 000 |
| H679SD2420040 | K042355 | 000 |
| H679SD4420040 | K042355 | 000 |
| H679021101500 | K042355 | 000 |
| H67902110150S0 | K042355 | 000 |
| H679021101510 | K042355 | 000 |
| H67902110151S0 | K042355 | 000 |
| H679021101520 | K042355 | 000 |
| H679041101500 | K042355 | 000 |