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 |