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FDA 510(k)

OSTEO CERCLAGE WIRE

K-Number: K914374 · 1991-12-30

ApplicantOsteo AG
Decision Date1991-12-30
Product CodeJDQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSTEO CERCLAGE WIRE is the device name listed in this FDA 510(k) record. The listed applicant is Osteo AG. It received FDA 510(k) clearance on 1991-12-30 under 510(k) number K914374. 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 CERCLAGE WIRE?

OSTEO CERCLAGE WIRE is a medical device that received FDA 510(k) clearance on 1991-12-30. The listed applicant is Osteo AG. The 510(k) number is K914374.

When did OSTEO CERCLAGE WIRE receive FDA 510(k) clearance?

OSTEO CERCLAGE WIRE received FDA 510(k) clearance on 1991-12-30, under 510(k) number K914374.

Who is the listed applicant for OSTEO CERCLAGE WIRE?

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

What is the FDA product code for OSTEO CERCLAGE WIRE?

The FDA product code for OSTEO CERCLAGE WIRE is JDQ.

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Other records listing Osteo AG 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.

K933340OSTEO INTERLOCKING-COMPRESSION NAILK922194OSTEO STEINMANN PINK922195OSTEO FEMORAL NAILK922196OSTEO TIBIA NAILK922193OSTEO KIRSCHNER WIREK920149OSTEO EX-FI-RE

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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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