Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

VITALA NATURAL RESORBABLE COLLAGEN MEMBRANE

K-Number: K101453 · 2011-07-21

Decision Date2011-07-21
Product CodeNPL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VITALA NATURAL RESORBABLE COLLAGEN MEMBRANE is the device name listed in this FDA 510(k) record. The listed applicant is Obi Biologics, Inc.. It received FDA 510(k) clearance on 2011-07-21 under 510(k) number K101453. The device is classified under product code NPL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITALA NATURAL RESORBABLE COLLAGEN MEMBRANE?

VITALA NATURAL RESORBABLE COLLAGEN MEMBRANE is a medical device that received FDA 510(k) clearance on 2011-07-21. The listed applicant is Obi Biologics, Inc.. The 510(k) number is K101453.

When did VITALA NATURAL RESORBABLE COLLAGEN MEMBRANE receive FDA 510(k) clearance?

VITALA NATURAL RESORBABLE COLLAGEN MEMBRANE received FDA 510(k) clearance on 2011-07-21, under 510(k) number K101453.

Who is the listed applicant for VITALA NATURAL RESORBABLE COLLAGEN MEMBRANE?

The FDA 510(k) record lists Obi Biologics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VITALA NATURAL RESORBABLE COLLAGEN MEMBRANE?

The FDA product code for VITALA NATURAL RESORBABLE COLLAGEN MEMBRANE is NPL.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: NPL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑