InterOss

Bone Grafting Material, Animal Source

SigmaGraft, Inc

The following data is part of a premarket notification filed by Sigmagraft, Inc with the FDA for Inteross.

Pre-market Notification Details

• Device ID: K151209
• 510k Number: K151209
• Device Name: InterOss
• Classification: Bone Grafting Material, Animal Source
• Applicant: SigmaGraft, Inc 335 N. Puente St. Unit A Brea, CA 92821
• Contact: Megan Holden
• Correspondent: Megan Holden; SigmaGraft, Inc 335 N. Puente St. Unit A Brea, CA 92821
• Product Code: NPM
• CFR Regulation Number: 872.3930 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-05-06
• Decision Date: 2015-11-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00841336111929	K151209	000
00852072007605	K151209	000
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00841336111936	K151209	000
00841336111943	K151209	000
00841336111950	K151209	000
00841336111998	K151209	000
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00855318006325	K151209	000