Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture Anchor, 3.5 x 13.5mm— 510(k) K150648

Name: FDA 510(k) clearance K150648
Creator: U.S. Food and Drug Administration
Published: 2015-08-20

Substantially Equivalent

Arthrex, Inc.

FDA 510(k) clearance K150648 for Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture Anchor, 3.5 x 13.5mm, Substantially Equivalent on 2015-08-20. Applicant: Arthrex, Inc.. Device class: 2.

Clearance details

Applicant: Arthrex, Inc.
Product code: Code MBI
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2015-03-12
Decision date: 2015-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naples, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MBI

view all

K253065 — Aevumed SUPERCYNCH Button System2026-09-02
K262809 — ArthroTAK Tendon Anchor Kit2026-09-02
K262677 — Iconix Knotless T2026-08-27
K262047 — Grappler Suture Anchor System2026-08-03
K262369 — AIR+ All-Inside Meniscal Repair Device, Curved Up; AIR+ All-Inside Meniscal Repair Device, Curved Down2026-07-30

More clearances from Arthrex, Inc.

view all

K262451 — Arthrex DynaNite Staples2026-09-01
K262357 — Arthrex Bioabsorbable PushLock Suture Anchors2026-08-07
K260624 — Arthrex Radial Head Replacement System2026-07-30
K260018 — Arthrex FiberButton2026-06-26
K260809 — Arthrex Sterile VAL and VAL KreuLock Compression Screw System2026-06-25

Adverse events under product code MBI

product code MBI

Injury: 3,163
Malfunction: 13,006
Other: 2
Total: 16,171

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 →

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