The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex K-wire ,threaded Models Ar-8990 To 899x, Ar-8991t To Ar-899xt.
| Device ID | K052736 |
| 510k Number | K052736 |
| Device Name: | ARTHREX K-WIRE ,THREADED MODELS AR-8990 TO 899X, AR-8991T TO AR-899XT |
| Classification | Pin, Fixation, Smooth |
| Applicant | ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
| Contact | Ann Waterhouse |
| Correspondent | Ann Waterhouse ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-30 |
| Decision Date | 2005-11-03 |
| Summary: | summary |