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FDA 510(k)

SC CERAMIC BALL HEADS

K-Number: K052237 · 2005-09-06

ApplicantOrthopedic Alliance, LLC
Decision Date2005-09-06
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SC CERAMIC BALL HEADS is the device name listed in this FDA 510(k) record. The listed applicant is Orthopedic Alliance, LLC. It received FDA 510(k) clearance on 2005-09-06 under 510(k) number K052237. 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 SC CERAMIC BALL HEADS?

SC CERAMIC BALL HEADS is a medical device that received FDA 510(k) clearance on 2005-09-06. The listed applicant is Orthopedic Alliance, LLC. The 510(k) number is K052237.

When did SC CERAMIC BALL HEADS receive FDA 510(k) clearance?

SC CERAMIC BALL HEADS received FDA 510(k) clearance on 2005-09-06, under 510(k) number K052237.

Who is the listed applicant for SC CERAMIC BALL HEADS?

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

What is the FDA product code for SC CERAMIC BALL HEADS?

The FDA product code for SC CERAMIC BALL HEADS is LZO.

Related Clinical Trials

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Other records listing Orthopedic Alliance, LLC as applicant

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.

K033826ORTHOPEDIC ALLIANCE SPINE SYSTEMK031474SC TOTAL HIP SYSTEM

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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