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FDA 510(k)

OSSE-LIGN, 1.5MM COCR AND SS CABLE SYSTEM AND COMPONENTS

K-Number: K040199 · 2004-02-20

ApplicantOsseus, LLC
Decision Date2004-02-20
Product CodeJDQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSSE-LIGN, 1.5MM COCR AND SS CABLE SYSTEM AND COMPONENTS is the device name listed in this FDA 510(k) record. The listed applicant is Osseus, LLC. It received FDA 510(k) clearance on 2004-02-20 under 510(k) number K040199. 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 OSSE-LIGN, 1.5MM COCR AND SS CABLE SYSTEM AND COMPONENTS?

OSSE-LIGN, 1.5MM COCR AND SS CABLE SYSTEM AND COMPONENTS is a medical device that received FDA 510(k) clearance on 2004-02-20. The listed applicant is Osseus, LLC. The 510(k) number is K040199.

When did OSSE-LIGN, 1.5MM COCR AND SS CABLE SYSTEM AND COMPONENTS receive FDA 510(k) clearance?

OSSE-LIGN, 1.5MM COCR AND SS CABLE SYSTEM AND COMPONENTS received FDA 510(k) clearance on 2004-02-20, under 510(k) number K040199.

Who is the listed applicant for OSSE-LIGN, 1.5MM COCR AND SS CABLE SYSTEM AND COMPONENTS?

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

What is the FDA product code for OSSE-LIGN, 1.5MM COCR AND SS CABLE SYSTEM AND COMPONENTS?

The FDA product code for OSSE-LIGN, 1.5MM COCR AND SS CABLE SYSTEM AND COMPONENTS is JDQ.

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Other records listing Osseus, 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.

K023564OSSE-LIGN

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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