MULTITAK CONICAL TIP BONE SOFT TISSUE SUTURE ANCHOR— 510(k) K010479

Name: FDA 510(k) clearance K010479
Creator: U.S. Food and Drug Administration
Published: 2001-05-08

Substantially Equivalent

Bonutti Research, Inc.

FDA 510(k) clearance K010479 for MULTITAK CONICAL TIP BONE SOFT TISSUE SUTURE ANCHOR, Substantially Equivalent on 2001-05-08. Applicant: Bonutti Research, Inc.. Device class: 2.

Clearance details

Applicant: Bonutti Research, Inc.
Product code: Code HTY
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2001-02-20
Decision date: 2001-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Effingham, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HTY

product code HTY

Injury: 544
Total: 544

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.