The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Titanium Corkscrew, 3.5 Mm, Arthrex Titanium Corkscrew, 5.0 Mm, Arthrex Titanium Corkscrew 6.5mm.
| Device ID | K003816 |
| 510k Number | K003816 |
| Device Name: | ARTHREX TITANIUM CORKSCREW, 3.5 MM, ARTHREX TITANIUM CORKSCREW, 5.0 MM, ARTHREX TITANIUM CORKSCREW 6.5MM |
| Classification | Screw, Fixation, Bone |
| 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 | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-11 |
| Decision Date | 2001-03-09 |
| Summary: | summary |