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FDA 510(k)

PIONEER LABORATORIES BONE PLATE WITH CERCLAGE CABLES

K-Number: K940729 · 1994-12-21

ApplicantPioneer Surgical Technology
Decision Date1994-12-21
Product CodeJDQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PIONEER LABORATORIES BONE PLATE WITH CERCLAGE CABLES is the device name listed in this FDA 510(k) record. The listed applicant is Pioneer Surgical Technology. It received FDA 510(k) clearance on 1994-12-21 under 510(k) number K940729. 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 PIONEER LABORATORIES BONE PLATE WITH CERCLAGE CABLES?

PIONEER LABORATORIES BONE PLATE WITH CERCLAGE CABLES is a medical device that received FDA 510(k) clearance on 1994-12-21. The listed applicant is Pioneer Surgical Technology. The 510(k) number is K940729.

When did PIONEER LABORATORIES BONE PLATE WITH CERCLAGE CABLES receive FDA 510(k) clearance?

PIONEER LABORATORIES BONE PLATE WITH CERCLAGE CABLES received FDA 510(k) clearance on 1994-12-21, under 510(k) number K940729.

Who is the listed applicant for PIONEER LABORATORIES BONE PLATE WITH CERCLAGE CABLES?

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

What is the FDA product code for PIONEER LABORATORIES BONE PLATE WITH CERCLAGE CABLES?

The FDA product code for PIONEER LABORATORIES BONE PLATE WITH CERCLAGE CABLES is JDQ.

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Other records listing Pioneer Surgical Technology 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.

K110561FORTROSS BONE VOID FILLERK101790QUANTUM SPINAL SYSTEM, QUANTUM MISK101525PIONEER SPINOUS PROCESS FUSION PLATEK093692QUANTUM/ STREAMLINE SPINAL SYSTEM MODEL 02-SERIES AND 10-SERIESK093771QUANTUM/STREAMLINE TL MIS SPINAL SYSTEMK100708PIONEER ANTERIOR CERVICAL PLATE MODEL 24-SERIES

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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