The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Lcp Proximal Humerus Plates, Long.
| Device ID | K041860 |
| 510k Number | K041860 |
| Device Name: | SYNTHES (USA) LCP PROXIMAL HUMERUS PLATES, LONG |
| 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 | 2004-07-09 |
| Decision Date | 2004-09-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679241925S0 | K041860 | 000 |
| H6794419250 | K041860 | 000 |
| H679441923S0 | K041860 | 000 |
| H6794419230 | K041860 | 000 |
| H679441921S0 | K041860 | 000 |
| H6794419210 | K041860 | 000 |
| H679441919S0 | K041860 | 000 |
| H6794419190 | K041860 | 000 |
| H679441918S0 | K041860 | 000 |
| H679441925S0 | K041860 | 000 |
| H6792419180 | K041860 | 000 |
| H6792419250 | K041860 | 000 |
| H679241923S0 | K041860 | 000 |
| H6792419230 | K041860 | 000 |
| H679241921S0 | K041860 | 000 |
| H6792419210 | K041860 | 000 |
| H679241919S0 | K041860 | 000 |
| H6792419190 | K041860 | 000 |
| H679241918S0 | K041860 | 000 |
| H6794419180 | K041860 | 000 |