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FDA 510(k)

FOUNDATION POROUS ACETABULAR COMPONENT

K-Number: K936043 · 1994-06-03

ApplicantEncore Orthopedics, Inc.
Decision Date1994-06-03
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FOUNDATION POROUS ACETABULAR COMPONENT 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 1994-06-03 under 510(k) number K936043. 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 POROUS ACETABULAR COMPONENT?

FOUNDATION POROUS ACETABULAR COMPONENT is a medical device that received FDA 510(k) clearance on 1994-06-03. The listed applicant is Encore Orthopedics, Inc.. The 510(k) number is K936043.

When did FOUNDATION POROUS ACETABULAR COMPONENT receive FDA 510(k) clearance?

FOUNDATION POROUS ACETABULAR COMPONENT received FDA 510(k) clearance on 1994-06-03, under 510(k) number K936043.

Who is the listed applicant for FOUNDATION POROUS ACETABULAR COMPONENT?

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 POROUS ACETABULAR COMPONENT?

The FDA product code for FOUNDATION POROUS ACETABULAR COMPONENT is JDI.

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Other records listing Encore 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.

K0329053DKNEE POROUS COATED FEMORAL COMPONENTK0201143D KNEEK020741UNICONDYLAR KNEEK020236MODIFICATION TO PASS SPINAL SYSTEMK020170KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UPK013490CEMENTED CALCAR HIP SYSTEM

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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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