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FDA 510(k)

Stitch Cerclage – Suture Tapes

K-Number: K243905 · 2025-08-14

ApplicantGM Dos Reis Industria e Comercio Ltda.
Decision Date2025-08-14
Product CodeJDQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Stitch Cerclage – Suture Tapes is the device name listed in this FDA 510(k) record. The listed applicant is GM Dos Reis Industria e Comercio Ltda.. It received FDA 510(k) clearance on 2025-08-14 under 510(k) number K243905. 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 Stitch Cerclage – Suture Tapes?

Stitch Cerclage – Suture Tapes is a medical device that received FDA 510(k) clearance on 2025-08-14. The listed applicant is GM Dos Reis Industria e Comercio Ltda.. The 510(k) number is K243905.

When did Stitch Cerclage – Suture Tapes receive FDA 510(k) clearance?

Stitch Cerclage – Suture Tapes received FDA 510(k) clearance on 2025-08-14, under 510(k) number K243905.

Who is the listed applicant for Stitch Cerclage – Suture Tapes?

The FDA 510(k) record lists GM Dos Reis Industria e Comercio Ltda. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Stitch Cerclage – Suture Tapes?

The FDA product code for Stitch Cerclage – Suture Tapes is JDQ.

Other records listing GM Dos Reis Industria e Comercio Ltda. 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.

K261406Versalock Proximal Tibial Plating SystemK260390Super Upper Limbs Versalock Plating SystemK254188Meniscus VersaflexK252664GMReis Suture AnchorsK243740Versalock Upper Limb Plating SystemK242998GMReis Ankle Plating System

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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.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.K230976Arthrex Radiopaque FiberTape Cerclage suturesArthrex, 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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