The following data is part of a premarket notification filed by Sapphire Medical Group, Inc with the FDA for A-wedge Anterior Interbody System (a-wedge Ais).
Device ID | K121693 |
510k Number | K121693 |
Device Name: | A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE AIS) |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
Applicant | SAPPHIRE MEDICAL GROUP, INC 815 IRIS LANE Vero Beach, FL 32963 |
Contact | Robert Poggie |
Correspondent | Robert Poggie SAPPHIRE MEDICAL GROUP, INC 815 IRIS LANE Vero Beach, FL 32963 |
Product Code | MAX |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-06-07 |
Decision Date | 2012-12-27 |
Summary: | summary |