The following data is part of a premarket notification filed by Synthes Usa with the FDA for 3.7mm/5.0mm Dynamic Locking Screw.
| Device ID | K110592 |
| 510k Number | K110592 |
| Device Name: | 3.7MM/5.0MM DYNAMIC LOCKING SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | SYNTHES USA 1301 GOSHEN PKWY West Chester, PA 19380 |
| Contact | Christopher Hack, Esq |
| Correspondent | Christopher Hack, Esq SYNTHES USA 1301 GOSHEN PKWY West Chester, PA 19380 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-02 |
| Decision Date | 2011-07-25 |
| Summary: | summary |