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FDA 510(k)

CLS ACETABULAR COMPONENT (MODIFICATION)

K-Number: K953688 · 1995-11-29

ApplicantIntermedics Orthopedics
Decision Date1995-11-29
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CLS ACETABULAR COMPONENT (MODIFICATION) is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics Orthopedics. It received FDA 510(k) clearance on 1995-11-29 under 510(k) number K953688. 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 CLS ACETABULAR COMPONENT (MODIFICATION)?

CLS ACETABULAR COMPONENT (MODIFICATION) is a medical device that received FDA 510(k) clearance on 1995-11-29. The listed applicant is Intermedics Orthopedics. The 510(k) number is K953688.

When did CLS ACETABULAR COMPONENT (MODIFICATION) receive FDA 510(k) clearance?

CLS ACETABULAR COMPONENT (MODIFICATION) received FDA 510(k) clearance on 1995-11-29, under 510(k) number K953688.

Who is the listed applicant for CLS ACETABULAR COMPONENT (MODIFICATION)?

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

What is the FDA product code for CLS ACETABULAR COMPONENT (MODIFICATION)?

The FDA product code for CLS ACETABULAR COMPONENT (MODIFICATION) is LZO.

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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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