BIOMEND EXTEND ABSORBABLE COLLAGEN MEMBRANE, BIOMEND ABSORBABLE COLLAGEN MENBRANE— 510(k) K992216

Name: FDA 510(k) clearance K992216
Creator: U.S. Food and Drug Administration
Published: 1999-07-26

Substantially Equivalent

Integra Lifesciences Corp.

FDA 510(k) clearance K992216 for BIOMEND EXTEND ABSORBABLE COLLAGEN MEMBRANE, BIOMEND ABSORBABLE COLLAGEN MENBRANE, Substantially Equivalent on 1999-07-26. Applicant: Integra Lifesciences Corp.. Device class: 2.

Clearance details

Applicant: Integra Lifesciences Corp.
Product code: Code LYC
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 1999-07-01
Decision date: 1999-07-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Plainsboro, NJ, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K992216

K-number listed on FDA's recall record

Z-1299-2013 — BioMend¿ Extend" Absorbable Collagen Membrane BioMend¿ Extend" Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus.Class II·Terminated·Integra LifeSciences Corporation·20130328

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K992216.

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