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FDA 510(k)

UNITED 36MM CERAMIC FEMORAL HEAD, DELTA

K-Number: K112463 · 2011-09-23

ApplicantUnited Orthopedic Corporation
Decision Date2011-09-23
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

UNITED 36MM CERAMIC FEMORAL HEAD, DELTA is the device name listed in this FDA 510(k) record. The listed applicant is United Orthopedic Corporation. It received FDA 510(k) clearance on 2011-09-23 under 510(k) number K112463. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNITED 36MM CERAMIC FEMORAL HEAD, DELTA?

UNITED 36MM CERAMIC FEMORAL HEAD, DELTA is a medical device that received FDA 510(k) clearance on 2011-09-23. The listed applicant is United Orthopedic Corporation. The 510(k) number is K112463.

When did UNITED 36MM CERAMIC FEMORAL HEAD, DELTA receive FDA 510(k) clearance?

UNITED 36MM CERAMIC FEMORAL HEAD, DELTA received FDA 510(k) clearance on 2011-09-23, under 510(k) number K112463.

Who is the listed applicant for UNITED 36MM CERAMIC FEMORAL HEAD, DELTA?

The FDA 510(k) record lists United Orthopedic Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNITED 36MM CERAMIC FEMORAL HEAD, DELTA?

The FDA product code for UNITED 36MM CERAMIC FEMORAL HEAD, DELTA is LZO.

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Other records listing United Orthopedic Corporation as applicant

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K253948Momentum Acetabular Cup SystemK252725Stem Extension Line (U2 Total Knee System—PSA Type)K252303Stem Extension Line (USTAR II System)K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaK242315Resolve Modular Revision Hip StemK243466Conformity Stem Extension Line, #0

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Related Devices (Code: LZO)

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.

K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.K253948Momentum Acetabular Cup SystemUnited Orthopedic CorporationK261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KGK260831Z1 Hip SystemZimmer, Inc.K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.K260037implantcast Packaging System UpdateImplantcast GmbH

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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