CONMED LINVATEC SOFT TISSUE TO BONE SYSTEM— 510(k) K091549

Name: FDA 510(k) clearance K091549
Creator: U.S. Food and Drug Administration
Published: 2009-06-23

Substantially Equivalent

Linvatec Corp.

FDA 510(k) clearance K091549 for CONMED LINVATEC SOFT TISSUE TO BONE SYSTEM, Substantially Equivalent on 2009-06-23. Applicant: Linvatec Corp.. Device class: 2.

Clearance details

Applicant: Linvatec Corp.
Product code: Code MBI
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2009-05-27
Decision date: 2009-06-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Largo, FL, US

Download summary PDF View on FDA.gov ↗

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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 →

Recalls naming K091549

K-number listed on FDA's recall record

Z-0253-2018 — Nonabsorbable suture anchor system intended to reattach soft tissue to bone in orthopedic surgical procedures may be used in either arthroscopic or open surgical procedures.Class II·Terminated·ConMed Corporation·20170417

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K091549.

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