Device Classification Name |
screw, fixation, bone
|
510(k) Number |
K121277 |
Device Name |
Z-SNAP OFF SCREW, Z-DOUBLE THREAD COMPRESSION SCREW, Z-GUIDE WIRE, Z-STAPLE |
Applicant |
Z-MEDICAL GMBH & CO. KG |
GANSACKER 38 |
TUTTLINGEN, BADEN-WUERTTEMBERG,
DE
78532
|
|
Applicant Contact |
ALEXANDER HENNINGER |
Correspondent |
Z-MEDICAL GMBH & CO. KG |
GANSACKER 38 |
TUTTLINGEN, BADEN-WUERTTEMBERG,
DE
78532
|
|
Correspondent Contact |
ALEXANDER HENNINGER |
Regulation Number | 888.3040
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/27/2012 |
Decision Date | 11/07/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|