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FDA 510(k)

HS Fiber Cerclage

K-Number: K220765 · 2023-07-26

ApplicantRiverpoint Medical, LLC
Decision Date2023-07-26
Product CodeJDQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HS Fiber Cerclage is the device name listed in this FDA 510(k) record. The listed applicant is Riverpoint Medical, LLC. It received FDA 510(k) clearance on 2023-07-26 under 510(k) number K220765. 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 HS Fiber Cerclage?

HS Fiber Cerclage is a medical device that received FDA 510(k) clearance on 2023-07-26. The listed applicant is Riverpoint Medical, LLC. The 510(k) number is K220765.

When did HS Fiber Cerclage receive FDA 510(k) clearance?

HS Fiber Cerclage received FDA 510(k) clearance on 2023-07-26, under 510(k) number K220765.

Who is the listed applicant for HS Fiber Cerclage?

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

What is the FDA product code for HS Fiber Cerclage?

The FDA product code for HS Fiber Cerclage is JDQ.

Other records listing Riverpoint Medical, LLC 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.

K253693Strut Suture; No-Tie ButtonK253695LigaMendK253024ProZip Knotless ImplantK252201HS FiberK252144Iconix Speed Anchor; Iconix Speed HA+ AnchorK243988RootMend MRR

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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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