The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) 3.5 And 4.5 Mm Locking Compression Plate System With Expanded Indications.
| Device ID | K082807 |
| 510k Number | K082807 |
| Device Name: | SYNTHES (USA) 3.5 AND 4.5 MM LOCKING COMPRESSION PLATE SYSTEM WITH EXPANDED INDICATIONS |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES (USA) 1301 GOSHEN PKWY. West Chester, PA 19380 |
| Contact | Jill R Sherman |
| Correspondent | Jill R Sherman 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 | 2008-09-24 |
| Decision Date | 2008-11-24 |
| Summary: | summary |