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FDA 510(k)

OSTEO-CLAGE(TM) CERCIAGE CABLE SYSTEM

K-Number: K921480 · 1992-06-26

ApplicantAcu-Med, Inc.
Decision Date1992-06-26
Product CodeJDQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSTEO-CLAGE(TM) CERCIAGE CABLE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Acu-Med, Inc.. It received FDA 510(k) clearance on 1992-06-26 under 510(k) number K921480. 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 OSTEO-CLAGE(TM) CERCIAGE CABLE SYSTEM?

OSTEO-CLAGE(TM) CERCIAGE CABLE SYSTEM is a medical device that received FDA 510(k) clearance on 1992-06-26. The listed applicant is Acu-Med, Inc.. The 510(k) number is K921480.

When did OSTEO-CLAGE(TM) CERCIAGE CABLE SYSTEM receive FDA 510(k) clearance?

OSTEO-CLAGE(TM) CERCIAGE CABLE SYSTEM received FDA 510(k) clearance on 1992-06-26, under 510(k) number K921480.

Who is the listed applicant for OSTEO-CLAGE(TM) CERCIAGE CABLE SYSTEM?

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

What is the FDA product code for OSTEO-CLAGE(TM) CERCIAGE CABLE SYSTEM?

The FDA product code for OSTEO-CLAGE(TM) CERCIAGE CABLE SYSTEM is JDQ.

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Other records listing Acu-Med, 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.

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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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