The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Modification To: Arthrex Interference Screw.
| Device ID | K071176 |
| 510k Number | K071176 |
| Device Name: | MODIFICATION TO: ARTHREX INTERFERENCE SCREW |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
| Contact | Ann Waterhouse, Rac |
| Correspondent | Ann Waterhouse, Rac ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-27 |
| Decision Date | 2007-08-03 |
| Summary: | summary |