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FDA 510(k)

SDB CERCLAGE SYSTEM

K-Number: K992616 · 1999-10-27

ApplicantPioneer Surgical Technology
Decision Date1999-10-27
Product CodeJDQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SDB CERCLAGE SYSTEM 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 1999-10-27 under 510(k) number K992616. 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 SDB CERCLAGE SYSTEM?

SDB CERCLAGE SYSTEM is a medical device that received FDA 510(k) clearance on 1999-10-27. The listed applicant is Pioneer Surgical Technology. The 510(k) number is K992616.

When did SDB CERCLAGE SYSTEM receive FDA 510(k) clearance?

SDB CERCLAGE SYSTEM received FDA 510(k) clearance on 1999-10-27, under 510(k) number K992616.

Who is the listed applicant for SDB CERCLAGE SYSTEM?

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 SDB CERCLAGE SYSTEM?

The FDA product code for SDB CERCLAGE SYSTEM 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

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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