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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Grafting Material, Animal Source
510(k) Number K221808
Device Name InterOss Collagen
Applicant
Sigmagraft, Inc.
575 Sally Pl.
Fullerton,  CA  92831
Applicant Contact Elcin Chang
Correspondent
Mtechgroup
7505 Fannin St.
Suite 610
Houston,  TX  77054
Correspondent Contact Dave Kim
Regulation Number872.3930
Classification Product Code
NPM  
Date Received06/22/2022
Decision Date 03/18/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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