VBR

Spinal Vertebral Body Replacement Device

OSTEOTECH, INC.

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

Pre-market Notification Details

• Device ID: K012254
• 510k Number: K012254
• Device Name: VBR
• 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: 2001-07-18
• Decision Date: 2001-10-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04052536000029	K012254	000
04052536009251	K012254	000
04052536009268	K012254	000
04052536009275	K012254	000
04052536076765	K012254	000
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04052536162291	K012254	000
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04052536162338	K012254	000
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04052536162369	K012254	000
04052536009244	K012254	000
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04052536009220	K012254	000
04052536004256	K012254	000
04052536004263	K012254	000
04052536004270	K012254	000
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04052536004331	K012254	000
04052536004348	K012254	000
04052536004355	K012254	000
04052536004362	K012254	000
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04052536004386	K012254	000
04052536004393	K012254	000
04052536004409	K012254	000
04052536004416	K012254	000
04052536004461	K012254	000
04052536009206	K012254	000
04052536009213	K012254	000
04052536162376	K012254	000
04052536162383	K012254	000
04052536162390	K012254	000
04052536179114	K012254	000
04052536179121	K012254	000
04052536179138	K012254	000
04052536179145	K012254	000
04052536179152	K012254	000
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04052536179183	K012254	000
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04052536179206	K012254	000
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04052536178995	K012254	000
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04052536179022	K012254	000
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04052536179053	K012254	000
04052536179060	K012254	000
04052536179077	K012254	000
04052536179282	K012254	000