The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Tenodesis Screw, 5.5 Mm, Model Ar-1350-55.
| Device ID | K011007 |
| 510k Number | K011007 |
| Device Name: | TENODESIS SCREW, 5.5 MM, MODEL AR-1350-55 |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| 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 | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-04 |
| Decision Date | 2001-06-12 |
| Summary: | summary |