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FDA 510(k)

PECTOFIX DYNAMIC STERNAL FIXATION SYSTEM (DSF)

K-Number: K000694 · 2000-05-11

ApplicantPectofix, Inc.
Decision Date2000-05-11
Product CodeJDQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PECTOFIX DYNAMIC STERNAL FIXATION SYSTEM (DSF) is the device name listed in this FDA 510(k) record. The listed applicant is Pectofix, Inc.. It received FDA 510(k) clearance on 2000-05-11 under 510(k) number K000694. 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 PECTOFIX DYNAMIC STERNAL FIXATION SYSTEM (DSF)?

PECTOFIX DYNAMIC STERNAL FIXATION SYSTEM (DSF) is a medical device that received FDA 510(k) clearance on 2000-05-11. The listed applicant is Pectofix, Inc.. The 510(k) number is K000694.

When did PECTOFIX DYNAMIC STERNAL FIXATION SYSTEM (DSF) receive FDA 510(k) clearance?

PECTOFIX DYNAMIC STERNAL FIXATION SYSTEM (DSF) received FDA 510(k) clearance on 2000-05-11, under 510(k) number K000694.

Who is the listed applicant for PECTOFIX DYNAMIC STERNAL FIXATION SYSTEM (DSF)?

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

What is the FDA product code for PECTOFIX DYNAMIC STERNAL FIXATION SYSTEM (DSF)?

The FDA product code for PECTOFIX DYNAMIC STERNAL FIXATION SYSTEM (DSF) is JDQ.

Related Clinical Trials

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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Other records listing Pectofix, 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.

K003951PECTOFIX STERNAL REPAIR WIRE

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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