The following data is part of a premarket notification filed by Anchor Innovation Medical, Inc. with the FDA for A.i.m. Suture Anchor.
| Device ID | K132461 |
| 510k Number | K132461 |
| Device Name: | A.I.M. SUTURE ANCHOR |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | ANCHOR INNOVATION MEDICAL, INC. 5410 EDSON LANE SUITE 308 Rockville, MD 20852 |
| Contact | Howard L Schrayer |
| Correspondent | Howard L Schrayer ANCHOR INNOVATION MEDICAL, INC. 5410 EDSON LANE SUITE 308 Rockville, MD 20852 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-07 |
| Decision Date | 2013-10-16 |
| Summary: | summary |