The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Fiberwire, Model Spu-02nb-3800.
| Device ID | K010673 |
| 510k Number | K010673 |
| Device Name: | ARTHREX FIBERWIRE, MODEL SPU-02NB-3800 |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | ARTHREX, INC. 2885 SOUTH HORSESHOE DR. Naples, FL 34104 |
| Contact | Brette Masino |
| Correspondent | Brette Masino 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 | 2001-03-06 |
| Decision Date | 2001-05-14 |