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FDA 510(k)

ALLOFIT ACETABULAR SYSTEM

K-Number: K003758 · 2001-03-07

ApplicantSulzer Orthopedics, Inc.
Decision Date2001-03-07
Product CodeKWA
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ALLOFIT 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 2001-03-07 under 510(k) number K003758. The device is classified under product code KWA. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALLOFIT ACETABULAR SYSTEM?

ALLOFIT ACETABULAR SYSTEM is a medical device that received FDA 510(k) clearance on 2001-03-07. The listed applicant is Sulzer Orthopedics, Inc.. The 510(k) number is K003758.

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

ALLOFIT ACETABULAR SYSTEM received FDA 510(k) clearance on 2001-03-07, under 510(k) number K003758.

Who is the listed applicant for ALLOFIT 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 ALLOFIT ACETABULAR SYSTEM?

The FDA product code for ALLOFIT ACETABULAR SYSTEM is KWA.

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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.

K022985ASCENDENT ACETABULAR SYSTEMK021578NATURAL-KNEE II SYSTEM COCR TIBIAL BASEPLATEK020713MS-30 LATERAL FEMORAL STEMK013935ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTSK013031MOST OPTIONS SYSTEMK012739CONVERGE ACETABULAR SYSTEM

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Related Devices (Code: KWA)

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.

K122778PROFEMUR Z REVISION HIP STEMWrightmedicaltechnologyincK121544DYNASTY BIOFOAM SHELLWrightmedicaltechnologyincK113271METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONSBiomet Manufacturing, Inc.K113322CONSERVE THIN SHELLWrightmedicaltechnologyincK112080PRESERVE HIP STEMWrightmedicaltechnologyincK112150PROFEMUR GLADIATOR HA HIP STEMWrightmedicaltechnologyinc

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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