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FDA 510(k)

VERTEBRAL BODY REPLACEMENT

K-Number: K003155 · 2001-01-04

ApplicantOsteotech, Inc.
Decision Date2001-01-04
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VERTEBRAL BODY REPLACEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Osteotech, Inc.. It received FDA 510(k) clearance on 2001-01-04 under 510(k) number K003155. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERTEBRAL BODY REPLACEMENT?

VERTEBRAL BODY REPLACEMENT is a medical device that received FDA 510(k) clearance on 2001-01-04. The listed applicant is Osteotech, Inc.. The 510(k) number is K003155.

When did VERTEBRAL BODY REPLACEMENT receive FDA 510(k) clearance?

VERTEBRAL BODY REPLACEMENT received FDA 510(k) clearance on 2001-01-04, under 510(k) number K003155.

Who is the listed applicant for VERTEBRAL BODY REPLACEMENT?

The FDA 510(k) record lists Osteotech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VERTEBRAL BODY REPLACEMENT?

The FDA product code for VERTEBRAL BODY REPLACEMENT is MQP.

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Other records listing Osteotech, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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