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FDA 510(k)

LINK, ACETABULAR REVISION MESH CUP

K-Number: K972760 · 1997-10-22

ApplicantLink America, Inc.
Decision Date1997-10-22
Product CodeJDJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LINK, ACETABULAR REVISION MESH CUP 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 1997-10-22 under 510(k) number K972760. The device is classified under product code JDJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LINK, ACETABULAR REVISION MESH CUP?

LINK, ACETABULAR REVISION MESH CUP is a medical device that received FDA 510(k) clearance on 1997-10-22. The listed applicant is Link America, Inc.. The 510(k) number is K972760.

When did LINK, ACETABULAR REVISION MESH CUP receive FDA 510(k) clearance?

LINK, ACETABULAR REVISION MESH CUP received FDA 510(k) clearance on 1997-10-22, under 510(k) number K972760.

Who is the listed applicant for LINK, ACETABULAR REVISION MESH CUP?

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, ACETABULAR REVISION MESH CUP?

The FDA product code for LINK, ACETABULAR REVISION MESH CUP is JDJ.

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Other records listing Link America, Inc. as applicant

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K964458ELLIS EXTERNAL MINI-FIXATOR SYSTEMK955296LINK MP RECONSTRUCTION HIPK954186SLED UNICOMPARTMENT KNEE SYSTEMK931571LINK CERAMIC HEADS 12/14 X 32MMK931572LINK CERAMIC HEADS 14/16 X 32MMK920756FELDMUHLE CERAMIC HEAD

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Related Devices (Code: JDJ)

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.

K970957OSTEONICS RESTORATION ACETABULAR RINGOsteonics Corp.K963940EXETER MESHHowmedica, Inc.K962541REFLECTION ACETABULAR REINFORCEMENT RINGSSmith & Nephew Richards, Inc.K962007PROTRUSION CAGESDepuy, Inc.K925883OSTEONICS MICROSTRUCTURED ACETABULAR COMPONENTSOsteonics Corp.K890450INTERMEDICS APR(TM) II FEMORAL COMPONENTIntermedics Orthopedics

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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