Device Classification Name |
Intervertebral Fusion Device With Bone Graft, Lumbar
|
510(k) Number |
K121693 |
Device Name |
A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE AIS) |
Applicant |
SAPPHIRE MEDICAL GROUP, INC |
815 IRIS LANE |
VERO BEACH,
FL
32963
|
|
Applicant Contact |
ROBERT POGGIE |
Correspondent |
SAPPHIRE MEDICAL GROUP, INC |
815 IRIS LANE |
VERO BEACH,
FL
32963
|
|
Correspondent Contact |
ROBERT POGGIE |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 06/07/2012 |
Decision Date | 12/27/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|