The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Limited Contact-dynamic Hip Screw Implant.
Device ID | K923613 |
510k Number | K923613 |
Device Name: | SYNTHES LIMITED CONTACT-DYNAMIC HIP SCREW IMPLANT |
Classification | Device, Fixation, Proximal Femoral, Implant |
Applicant | SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
Contact | Diane Cochet-wynant |
Correspondent | Diane Cochet-wynant SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
Product Code | JDO |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-21 |
Decision Date | 1993-06-22 |