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 |