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FDA 510(k)

METAGEN ACTIVELOCK WIRE CERCLAGE SYSTEM

K-Number: K983976 · 1998-12-30

ApplicantMetagen, LLC
Decision Date1998-12-30
Product CodeJDQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

METAGEN ACTIVELOCK WIRE CERCLAGE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Metagen, LLC. It received FDA 510(k) clearance on 1998-12-30 under 510(k) number K983976. The device is classified under product code JDQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the METAGEN ACTIVELOCK WIRE CERCLAGE SYSTEM?

METAGEN ACTIVELOCK WIRE CERCLAGE SYSTEM is a medical device that received FDA 510(k) clearance on 1998-12-30. The listed applicant is Metagen, LLC. The 510(k) number is K983976.

When did METAGEN ACTIVELOCK WIRE CERCLAGE SYSTEM receive FDA 510(k) clearance?

METAGEN ACTIVELOCK WIRE CERCLAGE SYSTEM received FDA 510(k) clearance on 1998-12-30, under 510(k) number K983976.

Who is the listed applicant for METAGEN ACTIVELOCK WIRE CERCLAGE SYSTEM?

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

What is the FDA product code for METAGEN ACTIVELOCK WIRE CERCLAGE SYSTEM?

The FDA product code for METAGEN ACTIVELOCK WIRE CERCLAGE SYSTEM is JDQ.

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Other records listing Metagen, LLC 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.

K980609SEGMENTAL DEFECT REPLACEMENT SYSTEMK980020ACTIVELOCK MODULAR FEMORAL HIP SYSTEMK964003METAGEN ALL POLY ACETABULAR CUP SYSTEMK963700METAGEN HIGH TIBIAL OSTEOTOMY SYSTEM

Related Devices (Code: JDQ)

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.

K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc.K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda.K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage SuturesArthrex, Inc.K232733Mbrace CableMedacta International S.A.K233949ACCORD Cable SystemSmith & Nephew, Inc.K232986VariTrax Sternal CircumFixation SystemCircumfix Solutions, Inc.

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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