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FDA 510(k)

ORTHOMATRIX, INC. CERCLAGE SYSTEM

K-Number: K001254 · 2000-12-13

ApplicantOrthomatrix, Inc.
Decision Date2000-12-13
Product CodeJDQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORTHOMATRIX, INC. CERCLAGE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Orthomatrix, Inc.. It received FDA 510(k) clearance on 2000-12-13 under 510(k) number K001254. 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 ORTHOMATRIX, INC. CERCLAGE SYSTEM?

ORTHOMATRIX, INC. CERCLAGE SYSTEM is a medical device that received FDA 510(k) clearance on 2000-12-13. The listed applicant is Orthomatrix, Inc.. The 510(k) number is K001254.

When did ORTHOMATRIX, INC. CERCLAGE SYSTEM receive FDA 510(k) clearance?

ORTHOMATRIX, INC. CERCLAGE SYSTEM received FDA 510(k) clearance on 2000-12-13, under 510(k) number K001254.

Who is the listed applicant for ORTHOMATRIX, INC. CERCLAGE SYSTEM?

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

What is the FDA product code for ORTHOMATRIX, INC. CERCLAGE SYSTEM?

The FDA product code for ORTHOMATRIX, INC. CERCLAGE SYSTEM is JDQ.

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Other records listing Orthomatrix, 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.

K010738CANNULATED PLUS SCREW SYSTEMK992856MAGELLAN HUMERAL INTRAMEDULLARY NAILK992850MAGELLAN TIBIAL INTRAMEDULLARY NAILK852766HA-1000 & HA-500 HYDROXYLAPATITE TOOTH ROOT SUBSTIK852765HA-2000 HYDROXYLAPATITEK851367HA-1000 & HA-500 HYDROXYLAPATITE-MODIFICATION

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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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