The following data is part of a premarket notification filed by Anchor Innovation Medical (a.i.m.) with the FDA for A.i.m. Knotless Meniscal Repair Device.
| Device ID | K133770 |
| 510k Number | K133770 |
| Device Name: | A.I.M. KNOTLESS MENISCAL REPAIR DEVICE |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | ANCHOR INNOVATION MEDICAL (A.I.M.) 5410 EDSON LANE, SUITE 308 Rockville, MD 20852 |
| Contact | Karen M Becker, Ph.d. |
| Correspondent | Karen M Becker, Ph.d. ANCHOR INNOVATION MEDICAL (A.I.M.) 5410 EDSON LANE, SUITE 308 Rockville, MD 20852 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-11 |
| Decision Date | 2014-06-10 |
| Summary: | summary |