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FDA 510(k)

ALL POLYETHYLENE CEMENTED ACETABULAR CUP

K-Number: K943696 · 1995-05-17

ApplicantDepuy, Inc.
Decision Date1995-05-17
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ALL POLYETHYLENE CEMENTED ACETABULAR CUP is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 1995-05-17 under 510(k) number K943696. 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 ALL POLYETHYLENE CEMENTED ACETABULAR CUP?

ALL POLYETHYLENE CEMENTED ACETABULAR CUP is a medical device that received FDA 510(k) clearance on 1995-05-17. The listed applicant is Depuy, Inc.. The 510(k) number is K943696.

When did ALL POLYETHYLENE CEMENTED ACETABULAR CUP receive FDA 510(k) clearance?

ALL POLYETHYLENE CEMENTED ACETABULAR CUP received FDA 510(k) clearance on 1995-05-17, under 510(k) number K943696.

Who is the listed applicant for ALL POLYETHYLENE CEMENTED ACETABULAR CUP?

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

What is the FDA product code for ALL POLYETHYLENE CEMENTED ACETABULAR CUP?

The FDA product code for ALL POLYETHYLENE CEMENTED ACETABULAR CUP is JDI.

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Other records listing Depuy, 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.

K043058PINNACLE CONSTRAINED ACETABULAR LINERSK042664LPS UPPER EXTREMITYK041085LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARYK033959LPSK040544DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -062K021478DELTA SHOULDER

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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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