MODIFICATION TO UNIGRAFT

Bone Grafting Material, Synthetic

UNICARE BIOMEDICAL, INC.

The following data is part of a premarket notification filed by Unicare Biomedical, Inc. with the FDA for Modification To Unigraft.

Pre-market Notification Details

• Device ID: K092567
• 510k Number: K092567
• Device Name: MODIFICATION TO UNIGRAFT
• Classification: Bone Grafting Material, Synthetic
• Applicant: UNICARE BIOMEDICAL, INC. 22971-B TRITON WAY Laguna Hills, CA 92653
• Contact: Stan Yang
• Correspondent: Stan Yang; UNICARE BIOMEDICAL, INC. 22971-B TRITON WAY Laguna Hills, CA 92653
• Product Code: LYC
• CFR Regulation Number: 872.3930 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-08-20
• Decision Date: 2009-11-25
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
D767U0302051	K092567	000
D767U0301051	K092567	000
D767U0102051	K092567	000
D767U0101051	K092567	000