Y-KNOT FLEX ALL-SUTURE ANCHOR, W/ TWO #2 (5 METRIC) HI-FI SUTURES, 1.8MM— 510(k) K131035

Name: FDA 510(k) clearance K131035
Creator: U.S. Food and Drug Administration
Published: 2013-07-02

Substantially Equivalent

Linvatec Corporation D/B/A Conmed Linvatec

FDA 510(k) clearance K131035 for Y-KNOT FLEX ALL-SUTURE ANCHOR, W/ TWO #2 (5 METRIC) HI-FI SUTURES, 1.8MM, Substantially Equivalent on 2013-07-02. Applicant: Linvatec Corporation D/B/A Conmed Linvatec. Device class: 2.

Clearance details

Applicant: Linvatec Corporation D/B/A Conmed Linvatec
Product code: Code MBI
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2013-04-12
Decision date: 2013-07-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Largo, FL, US

Download summary PDF View on FDA.gov ↗

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K130497 — D4000 DRIVE SYSTEM; D4000A DRIVE SYSTEM WITH IRRIGATION2013-03-29
K121890 — GENESYS PRESSFT SUTURE ANCHOR2012-08-22
K112965 — NANO SUTURE ANCHOR2011-11-02

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.