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FDA 510(k)

METAGEN ACTIVELOCK CERCLAGE SYSTEM

K-Number: K972327 · 1997-08-11

ApplicantPacific Materials and Interfaces
Decision Date1997-08-11
Product CodeJDQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

METAGEN ACTIVELOCK CERCLAGE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Pacific Materials and Interfaces. It received FDA 510(k) clearance on 1997-08-11 under 510(k) number K972327. 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 CERCLAGE SYSTEM?

METAGEN ACTIVELOCK CERCLAGE SYSTEM is a medical device that received FDA 510(k) clearance on 1997-08-11. The listed applicant is Pacific Materials and Interfaces. The 510(k) number is K972327.

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

METAGEN ACTIVELOCK CERCLAGE SYSTEM received FDA 510(k) clearance on 1997-08-11, under 510(k) number K972327.

Who is the listed applicant for METAGEN ACTIVELOCK CERCLAGE SYSTEM?

The FDA 510(k) record lists Pacific Materials and Interfaces as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Clinical Trials

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Other records listing Pacific Materials and Interfaces 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.

K983360MACROPORE PROTECTIVE SHEETK972913MACROPORE PROTECTIVE SHEET (PROTEGO 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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