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FDA 510(k)

ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT

K-Number: K032812 · 2003-12-08

ApplicantOrthovita, Inc.
Decision Date2003-12-08
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Orthovita, Inc.. It received FDA 510(k) clearance on 2003-12-08 under 510(k) number K032812. 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 ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT?

ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT is a medical device that received FDA 510(k) clearance on 2003-12-08. The listed applicant is Orthovita, Inc.. The 510(k) number is K032812.

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

ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT received FDA 510(k) clearance on 2003-12-08, under 510(k) number K032812.

Who is the listed applicant for ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT?

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

What is the FDA product code for ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT?

The FDA product code for ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT is MQP.

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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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