Arthrex SwiveLock Anchor— 510(k) K203495

Name: FDA 510(k) clearance K203495
Creator: U.S. Food and Drug Administration
Published: 2021-04-19

Substantially Equivalent

Arthrex, Inc.

FDA 510(k) clearance K203495 for Arthrex SwiveLock Anchor, Substantially Equivalent on 2021-04-19. 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: 2020-11-27
Decision date: 2021-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naples, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MAI

product code MAI

Injury: 1,948
Malfunction: 8,580
Total: 10,528

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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 K203495

K-number listed on FDA's recall record

Z-2107-2021 — Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCCClass II·Ongoing·Arthrex, Inc.·20210614

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K203495.

Data sourced from openFDA. This site is unofficial and independent of the FDA.