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FDA 510(k)

ORTHOVITA PEEK SPACER

K-Number: K101171 · 2011-01-25

ApplicantOrthovita, Inc.
Decision Date2011-01-25
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORTHOVITA PEEK SPACER is the device name listed in this FDA 510(k) record. The listed applicant is Orthovita, Inc.. It received FDA 510(k) clearance on 2011-01-25 under 510(k) number K101171. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHOVITA PEEK SPACER?

ORTHOVITA PEEK SPACER is a medical device that received FDA 510(k) clearance on 2011-01-25. The listed applicant is Orthovita, Inc.. The 510(k) number is K101171.

When did ORTHOVITA PEEK SPACER receive FDA 510(k) clearance?

ORTHOVITA PEEK SPACER received FDA 510(k) clearance on 2011-01-25, under 510(k) number K101171.

Who is the listed applicant for ORTHOVITA PEEK SPACER?

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 ORTHOVITA PEEK SPACER?

The FDA product code for ORTHOVITA PEEK SPACER is ODP.

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Related Devices (Code: ODP)

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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