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FDA 510(k)

PLASMAFIT ACETABULAR CUP AND VITELENE INSERT

K-Number: K122783 · 2013-10-30

ApplicantAesculap Implant System, Inc.
Decision Date2013-10-30
Product CodeOQG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PLASMAFIT ACETABULAR CUP AND VITELENE INSERT is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap Implant System, Inc.. It received FDA 510(k) clearance on 2013-10-30 under 510(k) number K122783. 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 PLASMAFIT ACETABULAR CUP AND VITELENE INSERT?

PLASMAFIT ACETABULAR CUP AND VITELENE INSERT is a medical device that received FDA 510(k) clearance on 2013-10-30. The listed applicant is Aesculap Implant System, Inc.. The 510(k) number is K122783.

When did PLASMAFIT ACETABULAR CUP AND VITELENE INSERT receive FDA 510(k) clearance?

PLASMAFIT ACETABULAR CUP AND VITELENE INSERT received FDA 510(k) clearance on 2013-10-30, under 510(k) number K122783.

Who is the listed applicant for PLASMAFIT ACETABULAR CUP AND VITELENE INSERT?

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

What is the FDA product code for PLASMAFIT ACETABULAR CUP AND VITELENE INSERT?

The FDA product code for PLASMAFIT ACETABULAR CUP AND VITELENE INSERT is OQG.

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Related Devices (Code: 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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