The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Compression Staple.
Device ID | K080111 |
510k Number | K080111 |
Device Name: | ARTHREX COMPRESSION STAPLE |
Classification | Staple, Fixation, Bone |
Applicant | ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
Contact | Sally Foust |
Correspondent | Sally Foust ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
Product Code | JDR |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-01-16 |
Decision Date | 2008-02-13 |
Summary: | summary |