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FDA 510(k)

EPSILON METASUL 32MM ACETABULAR INSERTS, STANDARD AND HOODED

K-Number: K033634 · 2004-09-15

ApplicantCenterpulse Orthopedics, Inc.
Decision Date2004-09-15
Product CodeKWA
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EPSILON METASUL 32MM ACETABULAR INSERTS, STANDARD AND HOODED is the device name listed in this FDA 510(k) record. The listed applicant is Centerpulse Orthopedics, Inc.. It received FDA 510(k) clearance on 2004-09-15 under 510(k) number K033634. 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 EPSILON METASUL 32MM ACETABULAR INSERTS, STANDARD AND HOODED?

EPSILON METASUL 32MM ACETABULAR INSERTS, STANDARD AND HOODED is a medical device that received FDA 510(k) clearance on 2004-09-15. The listed applicant is Centerpulse Orthopedics, Inc.. The 510(k) number is K033634.

When did EPSILON METASUL 32MM ACETABULAR INSERTS, STANDARD AND HOODED receive FDA 510(k) clearance?

EPSILON METASUL 32MM ACETABULAR INSERTS, STANDARD AND HOODED received FDA 510(k) clearance on 2004-09-15, under 510(k) number K033634.

Who is the listed applicant for EPSILON METASUL 32MM ACETABULAR INSERTS, STANDARD AND HOODED?

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

What is the FDA product code for EPSILON METASUL 32MM ACETABULAR INSERTS, STANDARD AND HOODED?

The FDA product code for EPSILON METASUL 32MM ACETABULAR INSERTS, STANDARD AND HOODED is KWA.

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Other records listing Centerpulse 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.

K033943ALPHA METASUL 28MM AND 32MM ACETABULAR INSERTS, STANDARD AND HOODEDK040947DURASUL BIPOLARK033810NATURAL-KNEE II UNICOMPARTMENTAL KNEE SYSTEMK033664MODIFICATION TO ALLOCLASSIC ZWEYMULLER SL OFFSET FEMORAL STEMK032348CONVERGE RETI-LOCK MULTI-HOLE REINFORCEMENT CUPK030923EPSILON DURASUL CONSTRAINED ACETABULAR LINER

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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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