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FDA 510(k)

INTER-OP DURASUL ACETABULAR INSERTS (4MM)

K-Number: K002575 · 2000-11-15

ApplicantSulzer Orthopedics, Inc.
Decision Date2000-11-15
Product CodeLWJ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INTER-OP DURASUL ACETABULAR INSERTS (4MM) 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 2000-11-15 under 510(k) number K002575. The device is classified under product code LWJ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTER-OP DURASUL ACETABULAR INSERTS (4MM)?

INTER-OP DURASUL ACETABULAR INSERTS (4MM) is a medical device that received FDA 510(k) clearance on 2000-11-15. The listed applicant is Sulzer Orthopedics, Inc.. The 510(k) number is K002575.

When did INTER-OP DURASUL ACETABULAR INSERTS (4MM) receive FDA 510(k) clearance?

INTER-OP DURASUL ACETABULAR INSERTS (4MM) received FDA 510(k) clearance on 2000-11-15, under 510(k) number K002575.

Who is the listed applicant for INTER-OP DURASUL ACETABULAR INSERTS (4MM)?

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 DURASUL ACETABULAR INSERTS (4MM)?

The FDA product code for INTER-OP DURASUL ACETABULAR INSERTS (4MM) is LWJ.

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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: LWJ)

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.

K120595UNISYN PLUS HIP STEMConsensus Orthopedics, Inc.K103518TRINITY ACETABULAR SYSTEMCorin USAK090764NOVATION CFS PRESS-FIT AND CEMENTED STEMSExactech, Inc.K082146METHA SHORT STEM HIP SYSTEM XL FEMORAL HEADAesculap Implant Systems, Inc.K07006136MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERTHayes Medical, Inc.K062978U2 HIP STEM, TI PLASMA SPRAYUnited Orthopedic Corp.

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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