The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex 4.5 Mm, 5.5 Mm And 6.5 Mm Corkscrew Ft.
Device ID | K061665 |
510k Number | K061665 |
Device Name: | ARTHREX 4.5 MM, 5.5 MM AND 6.5 MM CORKSCREW FT |
Classification | Screw, Fixation, Bone |
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 | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-06-14 |
Decision Date | 2006-07-25 |
Summary: | summary |