The following data is part of a premarket notification filed by Instrument Makar, Inc. with the FDA for Bioasbsorbable Mini-screw Suture Anchor.
| Device ID | K960555 |
| 510k Number | K960555 |
| Device Name: | BIOASBSORBABLE MINI-SCREW SUTURE ANCHOR |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | INSTRUMENT MAKAR, INC. C/O ABOOD,ABOOD & RHEAUME,P.C. 117 EAST ALLEGAN STREET Lansing, MI 48933 |
| Contact | Andrew P Abood |
| Correspondent | Andrew P Abood INSTRUMENT MAKAR, INC. C/O ABOOD,ABOOD & RHEAUME,P.C. 117 EAST ALLEGAN STREET Lansing, MI 48933 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-09 |
| Decision Date | 1996-07-09 |