The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Hydroxyapatite (ha) Coated Schanz Screws.
Device ID | K040701 |
510k Number | K040701 |
Device Name: | SYNTHES (USA) HYDROXYAPATITE (HA) COATED SCHANZ SCREWS |
Classification | Screw, Fixation, Bone |
Applicant | SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
Contact | Sheri L Musgnung |
Correspondent | Sheri L Musgnung SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-03-17 |
Decision Date | 2004-06-15 |
Summary: | summary |