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FDA 510(k)

LINK CONTOUR RIBBED HIP PROSTHESES SYSTEM

K-Number: K854465 · 1986-02-10

ApplicantLink America, Inc.
Decision Date1986-02-10
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LINK CONTOUR RIBBED HIP PROSTHESES SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Link America, Inc.. It received FDA 510(k) clearance on 1986-02-10 under 510(k) number K854465. 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 LINK CONTOUR RIBBED HIP PROSTHESES SYSTEM?

LINK CONTOUR RIBBED HIP PROSTHESES SYSTEM is a medical device that received FDA 510(k) clearance on 1986-02-10. The listed applicant is Link America, Inc.. The 510(k) number is K854465.

When did LINK CONTOUR RIBBED HIP PROSTHESES SYSTEM receive FDA 510(k) clearance?

LINK CONTOUR RIBBED HIP PROSTHESES SYSTEM received FDA 510(k) clearance on 1986-02-10, under 510(k) number K854465.

Who is the listed applicant for LINK CONTOUR RIBBED HIP PROSTHESES SYSTEM?

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

What is the FDA product code for LINK CONTOUR RIBBED HIP PROSTHESES SYSTEM?

The FDA product code for LINK CONTOUR RIBBED HIP PROSTHESES SYSTEM is JDI.

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Other records listing Link America, 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.

K972760LINK, ACETABULAR REVISION MESH CUPK964458ELLIS EXTERNAL MINI-FIXATOR SYSTEMK955296LINK MP RECONSTRUCTION HIPK954186SLED UNICOMPARTMENT KNEE SYSTEMK931571LINK CERAMIC HEADS 12/14 X 32MMK931572LINK CERAMIC HEADS 14/16 X 32MM

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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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