The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for 5.0mm Parachute Corkscrew Suture Anchor Model Ar-22255, 3.5mm Parachute Corkscrew Suture Anchor Model Ar-22235.
| Device ID | K974847 |
| 510k Number | K974847 |
| Device Name: | 5.0MM PARACHUTE CORKSCREW SUTURE ANCHOR MODEL AR-22255, 3.5MM PARACHUTE CORKSCREW SUTURE ANCHOR MODEL AR-22235 |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | ARTHREX, INC. 2885 SOUTH HORSESHOE DR. Naples, FL 34104 |
| Contact | Scott M Durlacher |
| Correspondent | Scott M Durlacher ARTHREX, INC. 2885 SOUTH HORSESHOE DR. Naples, FL 34104 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-29 |
| Decision Date | 1998-08-06 |
| Summary: | summary |