CYTOPLAST REGENTEX TITANIUM 250

Bone Grafting Material, Synthetic

OSTEOGENICS CO.

The following data is part of a premarket notification filed by Osteogenics Co. with the FDA for Cytoplast Regentex Titanium 250.

Pre-market Notification Details

• Device ID: K972278
• 510k Number: K972278
• Device Name: CYTOPLAST REGENTEX TITANIUM 250
• Classification: Bone Grafting Material, Synthetic
• Applicant: OSTEOGENICS CO. 6401 MEADOWS WEST DR. Fort Worth, TX 76132
• Contact: Richard A Hamer
• Correspondent: Richard A Hamer; OSTEOGENICS CO. 6401 MEADOWS WEST DR. Fort Worth, TX 76132
• Product Code: LYC
• CFR Regulation Number: 872.3930 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-06-18
• Decision Date: 1997-08-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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EFRIOSTRNRM25301	K972278	000
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