The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Lcp Proximal Humerus Plates.
| Device ID | K011815 |
| 510k Number | K011815 |
| Device Name: | SYNTHES LCP PROXIMAL HUMERUS PLATES |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Single Component |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Matthew M Hull |
| Correspondent | Matthew M Hull SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Product Code | KTW |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-11 |
| Decision Date | 2001-09-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6792419030 | K011815 | 000 |
| H6792419010 | K011815 | 000 |
| H6794419030 | K011815 | 000 |
| H6794419010 | K011815 | 000 |
| H6792411880 | K011815 | 000 |
| H6792411850 | K011815 | 000 |