The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Chondral Dart, Model Ar-4005b-18.
| Device ID | K991971 |
| 510k Number | K991971 |
| Device Name: | ARTHREX CHONDRAL DART, MODEL AR-4005B-18 |
| Classification | Pin, Fixation, Smooth |
| Applicant | ARTHREX, INC. 2885 SOUTH HORSESHOE DR. Naples, FL 34104 |
| Contact | Vernon C Brown |
| Correspondent | Vernon C Brown ARTHREX, INC. 2885 SOUTH HORSESHOE DR. Naples, FL 34104 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-11 |
| Decision Date | 2000-08-04 |
| Summary: | summary |