FDA 510(k)

InterOss Collagen

K-Number: K221808 · 2023-03-18

Decision Date2023-03-18

Product CodeNPM

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

InterOss Collagen is the device name listed in this FDA 510(k) record. The listed applicant is Sigmagraft, Inc.. It received FDA 510(k) clearance on 2023-03-18 under 510(k) number K221808. The device is classified under product code NPM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the InterOss Collagen?

InterOss Collagen is a medical device that received FDA 510(k) clearance on 2023-03-18. The listed applicant is Sigmagraft, Inc.. The 510(k) number is K221808.

When did InterOss Collagen receive FDA 510(k) clearance?

InterOss Collagen received FDA 510(k) clearance on 2023-03-18, under 510(k) number K221808.

Who is the listed applicant for InterOss Collagen?

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

What is the FDA product code for InterOss Collagen?

The FDA product code for InterOss Collagen is NPM.

Other records listing Sigmagraft, Inc. as applicant

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.

K223912InterCollagen® Guide

Related Devices (Code: NPM)

K253723BOSSMedpark Co., Ltd.K251786Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®Geistlich Pharma AG K251613SwissGraft XGeistlich Pharma AG K242510Geistlich Bio-Flow®Geistlich Pharma AG K240133Xenograft Bovine Bone ParticulateCollagen Solutions, LLC K230305THE Graft CollagenPurgo Biologics, Inc.

Official Source

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