The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Fiberwire, Usp Size 5, Model Ar-7201.
| Device ID | K012923 |
| 510k Number | K012923 |
| Device Name: | ARTHREX FIBERWIRE, USP SIZE 5, MODEL AR-7201 |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | ARTHREX, INC. 2885 SOUTH HORSESHOE DR. Naples, FL 34104 |
| Contact | Ann Waterhouse |
| Correspondent | Ann Waterhouse ARTHREX, INC. 2885 SOUTH HORSESHOE DR. Naples, FL 34104 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-31 |
| Decision Date | 2001-10-04 |
| Summary: | summary |