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FDA 510(k)

VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERT

K-Number: K130652 · 2013-12-17

ApplicantConsensus Orthopedics, Inc.
Decision Date2013-12-17
Product CodeOQG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERT is the device name listed in this FDA 510(k) record. The listed applicant is Consensus Orthopedics, Inc.. It received FDA 510(k) clearance on 2013-12-17 under 510(k) number K130652. The device is classified under product code OQG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERT?

VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERT is a medical device that received FDA 510(k) clearance on 2013-12-17. The listed applicant is Consensus Orthopedics, Inc.. The 510(k) number is K130652.

When did VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERT receive FDA 510(k) clearance?

VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERT received FDA 510(k) clearance on 2013-12-17, under 510(k) number K130652.

Who is the listed applicant for VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERT?

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

What is the FDA product code for VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERT?

The FDA product code for VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERT is OQG.

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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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