VERTEBRAL BODY REPLACEMENT

Spinal Vertebral Body Replacement Device

OSTEOTECH, INC.

The following data is part of a premarket notification filed by Osteotech, Inc. with the FDA for Vertebral Body Replacement.

Pre-market Notification Details

• Device ID: K003155
• 510k Number: K003155
• Device Name: VERTEBRAL BODY REPLACEMENT
• Classification: Spinal Vertebral Body Replacement Device
• Applicant: OSTEOTECH, INC. 51 JAMES WAY Eatontown, NJ 07724
• Contact: Kim Thurman
• Correspondent: Kim Thurman; OSTEOTECH, INC. 51 JAMES WAY Eatontown, NJ 07724
• Product Code: MQP
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-10-10
• Decision Date: 2001-01-04

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04052536003549	K003155	000
04052536003730	K003155	000
04052536003747	K003155	000
04052536003754	K003155	000
04052536003761	K003155	000
04052536003778	K003155	000
04052536003785	K003155	000
04052536003792	K003155	000
04052536003808	K003155	000
04052536003815	K003155	000
04052536003822	K003155	000
04052536003839	K003155	000
04052536003846	K003155	000
04052536003853	K003155	000
04052536003860	K003155	000
04052536003877	K003155	000
04052536003723	K003155	000
04052536003716	K003155	000
04052536003709	K003155	000
04052536003556	K003155	000
04052536003563	K003155	000
04052536003570	K003155	000
04052536003587	K003155	000
04052536003594	K003155	000
04052536003600	K003155	000
04052536003617	K003155	000
04052536003624	K003155	000
04052536003631	K003155	000
04052536003648	K003155	000
04052536003655	K003155	000
04052536003662	K003155	000
04052536003679	K003155	000
04052536003686	K003155	000
04052536003693	K003155	000
04052536003884	K003155	000
04052536003891	K003155	000
04052536004157	K003155	000
04052536004164	K003155	000
04052536004171	K003155	000
04052536076048	K003155	000
04052536076055	K003155	000
04052536076062	K003155	000
04052536076079	K003155	000
04052536076086	K003155	000
04052536076093	K003155	000
04052536076109	K003155	000
04052536076116	K003155	000
04052536076123	K003155	000
04052536076130	K003155	000
04052536076147	K003155	000
04052536076154	K003155	000
04052536004140	K003155	000
04052536004133	K003155	000
04052536004126	K003155	000
04052536003976	K003155	000
04052536003983	K003155	000
04052536003990	K003155	000
04052536004003	K003155	000
04052536004010	K003155	000
04052536004027	K003155	000
04052536004034	K003155	000
04052536004041	K003155	000
04052536004058	K003155	000
04052536004065	K003155	000
04052536004072	K003155	000
04052536004089	K003155	000
04052536004096	K003155	000
04052536004102	K003155	000
04052536004119	K003155	000
04052536076161	K003155	000