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FDA 510(k)

TransLoc 3D

K-Number: K211496 · 2022-07-27

ApplicantFoundation Fusion Solutions, LLC (Dba Cornerloc)
Decision Date2022-07-27
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TransLoc 3D is a medical device manufactured by Foundation Fusion Solutions, LLC (Dba Cornerloc). It received FDA 510(k) clearance on 2022-07-27 under approval number K211496. 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 TransLoc 3D?

TransLoc 3D is a medical device that received FDA 510(k) clearance on 2022-07-27. It is manufactured by Foundation Fusion Solutions, LLC (Dba Cornerloc). The 510(k) number is K211496.

When was TransLoc 3D approved by the FDA?

TransLoc 3D received FDA 510(k) clearance on 2022-07-27, under approval number K211496.

What company makes TransLoc 3D?

TransLoc 3D is manufactured by Foundation Fusion Solutions, LLC (Dba Cornerloc).

What is the FDA product code for TransLoc 3D?

The FDA product code for TransLoc 3D is OUR.

Other Devices by Foundation Fusion Solutions, LLC (Dba Cornerloc)

K232878TransLoc 3D

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. K152237The Entasis Dual-Lead Sacroiliac ImplantCorelink, LLC

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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