510(k) K101823 ยท MAI Fastener, Fixation, Biodegradable, Soft Tissue
ARTHREX SWIVELOCK ANCHORS
| Applicant | Arthrex, Inc., Naples FL, US |
| Decision | Substantially Equivalent, Jan 7, 2011 |
| Received | Jun 30, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101823
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 24, 2017 | Arthrex, Inc. Anthrex Bio-SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching Terminated |
MAI | None listed |
| Mar 24, 2017 | Arthrex, Inc. Anthrex PEEK SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching Terminated |
MAI | None listed |
| Mar 24, 2017 | Arthrex, Inc. Anthrex Bio Composite SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching Terminated |
MAI | None listed |
| Mar 24, 2017 | Arthrex, Inc. Anthrex PEEK SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching Terminated |
MAI | None listed |
| Mar 24, 2017 | Arthrex, Inc. Anthrex SpeedBridge Implant System with BioComposite SwiveLock SP Vented, 5.5 mm x 24 mm Terminated |
MAI | None listed |
| Mar 24, 2017 | Arthrex, Inc. Anthrex SpeedBridge Implant System with PEEK SwiveLock Self Punching Terminated |
MAI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.