The following data is part of a premarket notification filed by Z-medical Gmbh & Co. Kg with the FDA for Z-snap Off Screw, Z-double Thread Compression Screw, Z-guide Wire, Z-staple.
Device ID | K121277 |
510k Number | K121277 |
Device Name: | Z-SNAP OFF SCREW, Z-DOUBLE THREAD COMPRESSION SCREW, Z-GUIDE WIRE, Z-STAPLE |
Classification | Screw, Fixation, Bone |
Applicant | Z-MEDICAL GMBH & CO. KG GANSACKER 38 Tuttlingen, Baden-wuerttemberg, DE 78532 |
Contact | Alexander Henninger |
Correspondent | Alexander Henninger Z-MEDICAL GMBH & CO. KG GANSACKER 38 Tuttlingen, Baden-wuerttemberg, DE 78532 |
Product Code | HWC |
Subsequent Product Code | HTY |
Subsequent Product Code | JDR |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-04-27 |
Decision Date | 2012-11-07 |
Summary: | summary |