ARTHREX SWIVELOCK ANCHORS— 510(k) K101823
Substantially EquivalentArthrex, Inc.
FDA 510(k) clearance K101823 for ARTHREX SWIVELOCK ANCHORS, Substantially Equivalent on 2011-01-07. Applicant: Arthrex, Inc.. Device class: 2.
Clearance details
- Applicant
- Arthrex, Inc.
- Product code
- Code MAI
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Naples, FL, US
Recent devices under product code MAI
view allMore clearances from Arthrex, Inc.
view allAdverse events under product code MAI
product code MAI- Injury
- 1,948
- Malfunction
- 8,580
- Total
- 10,528
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K101823
K-number listed on FDA's recall record- Z-2041-2017 — Anthrex Bio-SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching
- Z-2042-2017 — Anthrex PEEK SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching
- Z-2043-2017 — Anthrex Bio Composite SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching
- Z-2044-2017 — Anthrex PEEK SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching
- Z-2045-2017 — Anthrex SpeedBridge Implant System with BioComposite SwiveLock SP Vented, 5.5 mm x 24 mm
- Z-2046-2017 — Anthrex SpeedBridge Implant System with PEEK SwiveLock Self Punching
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K101823.
Data sourced from openFDA. This site is unofficial and independent of the FDA.