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FDA 510(k)

ASCENDENT ACETABULAR SYSTEM

K-Number: K022985 · 2002-12-05

ApplicantSulzer Orthopedics, Inc.
Decision Date2002-12-05
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ASCENDENT ACETABULAR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sulzer Orthopedics, Inc.. It received FDA 510(k) clearance on 2002-12-05 under 510(k) number K022985. 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 ASCENDENT ACETABULAR SYSTEM?

ASCENDENT ACETABULAR SYSTEM is a medical device that received FDA 510(k) clearance on 2002-12-05. The listed applicant is Sulzer Orthopedics, Inc.. The 510(k) number is K022985.

When did ASCENDENT ACETABULAR SYSTEM receive FDA 510(k) clearance?

ASCENDENT ACETABULAR SYSTEM received FDA 510(k) clearance on 2002-12-05, under 510(k) number K022985.

Who is the listed applicant for ASCENDENT ACETABULAR SYSTEM?

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

What is the FDA product code for ASCENDENT ACETABULAR SYSTEM?

The FDA product code for ASCENDENT ACETABULAR SYSTEM is LZO.

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Other records listing Sulzer Orthopedics, Inc. 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.

K021578NATURAL-KNEE II SYSTEM COCR TIBIAL BASEPLATEK020713MS-30 LATERAL FEMORAL STEMK013935ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTSK013031MOST OPTIONS SYSTEMK012739CONVERGE ACETABULAR SYSTEMK012961SULZER ORTHOPEDICS CONVERGE ACETABULAR SYSTEM

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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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