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FDA 510(k)

SYNTHES STERNAL FIXATION SYSTEM

K-Number: K010943 · 2001-06-27

ApplicantSynthes (Usa)
Decision Date2001-06-27
Product CodeJDQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNTHES STERNAL FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa). It received FDA 510(k) clearance on 2001-06-27 under 510(k) number K010943. 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 SYNTHES STERNAL FIXATION SYSTEM?

SYNTHES STERNAL FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2001-06-27. The listed applicant is Synthes (Usa). The 510(k) number is K010943.

When did SYNTHES STERNAL FIXATION SYSTEM receive FDA 510(k) clearance?

SYNTHES STERNAL FIXATION SYSTEM received FDA 510(k) clearance on 2001-06-27, under 510(k) number K010943.

Who is the listed applicant for SYNTHES STERNAL FIXATION SYSTEM?

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

What is the FDA product code for SYNTHES STERNAL FIXATION SYSTEM?

The FDA product code for SYNTHES STERNAL FIXATION SYSTEM is JDQ.

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Other records listing Synthes (Usa) 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.

K121601SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATEK120854SYNTHES VA LCP ANKLE TRAUMA SYSTEMK120717SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)K120070SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEMK120083SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN)K111667SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS

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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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