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FDA 510(k)

METAGEN ALL POLY ACETABULAR CUP SYSTEM

K-Number: K964003 · 1997-03-21

ApplicantMetagen, LLC
Decision Date1997-03-21
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

METAGEN ALL POLY ACETABULAR CUP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Metagen, LLC. It received FDA 510(k) clearance on 1997-03-21 under 510(k) number K964003. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the METAGEN ALL POLY ACETABULAR CUP SYSTEM?

METAGEN ALL POLY ACETABULAR CUP SYSTEM is a medical device that received FDA 510(k) clearance on 1997-03-21. The listed applicant is Metagen, LLC. The 510(k) number is K964003.

When did METAGEN ALL POLY ACETABULAR CUP SYSTEM receive FDA 510(k) clearance?

METAGEN ALL POLY ACETABULAR CUP SYSTEM received FDA 510(k) clearance on 1997-03-21, under 510(k) number K964003.

Who is the listed applicant for METAGEN ALL POLY ACETABULAR CUP SYSTEM?

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

What is the FDA product code for METAGEN ALL POLY ACETABULAR CUP SYSTEM?

The FDA product code for METAGEN ALL POLY ACETABULAR CUP SYSTEM is JDI.

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Other records listing Metagen, LLC 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.

K983976METAGEN ACTIVELOCK WIRE CERCLAGE SYSTEMK980609SEGMENTAL DEFECT REPLACEMENT SYSTEMK980020ACTIVELOCK MODULAR FEMORAL HIP SYSTEMK963700METAGEN HIGH TIBIAL OSTEOTOMY SYSTEM

Related Devices (Code: JDI)

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.

K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.K253434OSSTM Orthopedic Salvage SystemBiomet, Inc.K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersZimmer BiometK240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip StemsSmith & Nephew, Inc.K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee ComponentHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics

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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