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FDA 510(k)

EXETER MESH

K-Number: K963940 · 1997-02-13

ApplicantHowmedica, Inc.
Decision Date1997-02-13
Product CodeJDJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EXETER MESH is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica, Inc.. It received FDA 510(k) clearance on 1997-02-13 under 510(k) number K963940. 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 EXETER MESH?

EXETER MESH is a medical device that received FDA 510(k) clearance on 1997-02-13. The listed applicant is Howmedica, Inc.. The 510(k) number is K963940.

When did EXETER MESH receive FDA 510(k) clearance?

EXETER MESH received FDA 510(k) clearance on 1997-02-13, under 510(k) number K963940.

Who is the listed applicant for EXETER MESH?

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

What is the FDA product code for EXETER MESH?

The FDA product code for EXETER MESH is JDJ.

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Other records listing Howmedica, 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.

K984251XIA SPINE SYSTEMK984202HOWMEDICA HUMERAL INTERCALARY SYSTEMK984305ZETA MULTIZONE LOCKING NAIL SYSTEMK983885BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATESK983358G/K SFN AND STN LOCKING NAILSK982463EXTRACRANIAL RADIOTHERAPY SYSTEM

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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.

K972760LINK, ACETABULAR REVISION MESH CUPLink America, Inc.K970957OSTEONICS RESTORATION ACETABULAR RINGOsteonics Corp.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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