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FDA 510(k)

The Entasis Dual-Lead Sacroiliac Implant

K-Number: K152237 · 2016-02-04

ApplicantCorelink, LLC
Decision Date2016-02-04
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

The Entasis Dual-Lead Sacroiliac Implant is a medical device manufactured by Corelink, LLC. It received FDA 510(k) clearance on 2016-02-04 under approval number K152237. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the The Entasis Dual-Lead Sacroiliac Implant?

The Entasis Dual-Lead Sacroiliac Implant is a medical device that received FDA 510(k) clearance on 2016-02-04. It is manufactured by Corelink, LLC. The 510(k) number is K152237.

When was The Entasis Dual-Lead Sacroiliac Implant approved by the FDA?

The Entasis Dual-Lead Sacroiliac Implant received FDA 510(k) clearance on 2016-02-04, under approval number K152237.

What company makes The Entasis Dual-Lead Sacroiliac Implant?

The Entasis Dual-Lead Sacroiliac Implant is manufactured by Corelink, LLC.

What is the FDA product code for The Entasis Dual-Lead Sacroiliac Implant?

The FDA product code for The Entasis Dual-Lead Sacroiliac Implant is OUR.

Related Clinical Trials

NCT07565545 Posterior-Inferior Intra-articular Cortical Piercing Titanium Implant for Sacroiliac Joint Fusion: Evaluation of Safety and Effectiveness Outcomes NOT_YET_RECRUITING NCT05367505 Titanium Fusion Implant in Combination With Trans-iliac Screws for Insufficiency Fractures of the Pelvis RECRUITING

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Related Devices (Code: OUR)

K161755Integrity-SI TM Fusion SystemCoorstek Medical K153656PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd. K161210RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) SystemsMedtronic Sofamor Danek K160652iFUSE Implant SystemSI-BONE, Inc. K152681iFuse Implant System(R)SI-BONE, Inc. K171595M.U.S.T. Sacral Iliac Screw and Pelvic Trauma SystemMedacta International S.A.

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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