The following data is part of a premarket notification filed by Instrument Makar, Inc. with the FDA for Bioabsorbable Interference Screw.
| Device ID | K943249 |
| 510k Number | K943249 |
| Device Name: | BIOABSORBABLE INTERFERENCE SCREW |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | INSTRUMENT MAKAR, INC. 555 THIRTEENTH ST. N.W. Washington, DC 20004 |
| Contact | Partricia B Shrader |
| Correspondent | Partricia B Shrader INSTRUMENT MAKAR, INC. 555 THIRTEENTH ST. N.W. Washington, DC 20004 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-06 |
| Decision Date | 1995-07-31 |