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FDA 510(k)

FOUNDATION ALL POLY CUP

K-Number: K934169 · 1994-05-03

ApplicantEncore Orthopedics, Inc.
Decision Date1994-05-03
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FOUNDATION ALL POLY CUP is the device name listed in this FDA 510(k) record. The listed applicant is Encore Orthopedics, Inc.. It received FDA 510(k) clearance on 1994-05-03 under 510(k) number K934169. 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 FOUNDATION ALL POLY CUP?

FOUNDATION ALL POLY CUP is a medical device that received FDA 510(k) clearance on 1994-05-03. The listed applicant is Encore Orthopedics, Inc.. The 510(k) number is K934169.

When did FOUNDATION ALL POLY CUP receive FDA 510(k) clearance?

FOUNDATION ALL POLY CUP received FDA 510(k) clearance on 1994-05-03, under 510(k) number K934169.

Who is the listed applicant for FOUNDATION ALL POLY CUP?

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

What is the FDA product code for FOUNDATION ALL POLY CUP?

The FDA product code for FOUNDATION ALL POLY CUP is JDI.

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Related Devices (Code: JDI)

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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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