VersaWrap Tendon Protector— 510(k) K200311

Name: FDA 510(k) clearance K200311
Creator: U.S. Food and Drug Administration
Published: 2020-03-06

Substantially Equivalent

Alafair Biosciences, Inc.

FDA 510(k) clearance K200311 for VersaWrap Tendon Protector, Substantially Equivalent on 2020-03-06. Applicant: Alafair Biosciences, Inc.. Device class: 2.

Clearance details

Applicant: Alafair Biosciences, Inc.
Product code: Code FTM
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2020-02-06
Decision date: 2020-03-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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More clearances from Alafair Biosciences, Inc.

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K240817 — VersaWrap2024-06-14
K232029 — VersaWrap Nerve Protector2023-11-02
K213163 — VersaWrap2021-10-29
K203600 — VersaWrap2021-03-09
K201631 — VersaWrap Nerve Protector2020-09-14

Adverse events under product code FTM

product code FTM

Death: 17
Injury: 2,174
Total: 2,191

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.