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FDA 510(k)

INTER-OP METASUL HOODED AND PROTRUSIO ACETABULAR INSERTS

K-Number: K001536 · 2000-07-27

ApplicantSulzer Orthopedics, Inc.
Decision Date2000-07-27
Product CodeKWA
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INTER-OP METASUL HOODED AND PROTRUSIO ACETABULAR INSERTS 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 2000-07-27 under 510(k) number K001536. 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 INTER-OP METASUL HOODED AND PROTRUSIO ACETABULAR INSERTS?

INTER-OP METASUL HOODED AND PROTRUSIO ACETABULAR INSERTS is a medical device that received FDA 510(k) clearance on 2000-07-27. The listed applicant is Sulzer Orthopedics, Inc.. The 510(k) number is K001536.

When did INTER-OP METASUL HOODED AND PROTRUSIO ACETABULAR INSERTS receive FDA 510(k) clearance?

INTER-OP METASUL HOODED AND PROTRUSIO ACETABULAR INSERTS received FDA 510(k) clearance on 2000-07-27, under 510(k) number K001536.

Who is the listed applicant for INTER-OP METASUL HOODED AND PROTRUSIO ACETABULAR INSERTS?

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 INTER-OP METASUL HOODED AND PROTRUSIO ACETABULAR INSERTS?

The FDA product code for INTER-OP METASUL HOODED AND PROTRUSIO ACETABULAR INSERTS 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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