The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes 4.5 Mm Lcp Posterolateral Proximal Femur Plates.
| Device ID | K070208 |
| 510k Number | K070208 |
| Device Name: | SYNTHES 4.5 MM LCP POSTEROLATERAL PROXIMAL FEMUR PLATES |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES (USA) 1301 GOSHEN PKWY West Chester, PA 19380 |
| Contact | Sheri L Musgnung |
| Correspondent | Sheri L Musgnung SYNTHES (USA) 1301 GOSHEN PKWY West Chester, PA 19380 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-22 |
| Decision Date | 2007-03-28 |
| Summary: | summary |