The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Rapidsorb Plus Screw System.
| Device ID | K093464 |
| 510k Number | K093464 |
| Device Name: | RAPIDSORB PLUS SCREW SYSTEM |
| Classification | Screw, Fixation, Intraosseous |
| Applicant | SYNTHES (USA) 1230 WILSON DRIVE West Chester, PA 19380 |
| Contact | Susan Lewandowski |
| Correspondent | Susan Lewandowski SYNTHES (USA) 1230 WILSON DRIVE West Chester, PA 19380 |
| Product Code | DZL |
| CFR Regulation Number | 872.4880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-06 |
| Decision Date | 2010-01-25 |
| Summary: | summary |