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FDA 510(k)

SIMPACT Sacroiliac Joint Fixation System

K-Number: K212903 · 2021-12-15

ApplicantLife Spine, Inc.
Decision Date2021-12-15
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SIMPACT Sacroiliac Joint Fixation System is a medical device manufactured by Life Spine, Inc.. It received FDA 510(k) clearance on 2021-12-15 under approval number K212903. 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 SIMPACT Sacroiliac Joint Fixation System?

SIMPACT Sacroiliac Joint Fixation System is a medical device that received FDA 510(k) clearance on 2021-12-15. It is manufactured by Life Spine, Inc.. The 510(k) number is K212903.

When was SIMPACT Sacroiliac Joint Fixation System approved by the FDA?

SIMPACT Sacroiliac Joint Fixation System received FDA 510(k) clearance on 2021-12-15, under approval number K212903.

What company makes SIMPACT Sacroiliac Joint Fixation System?

SIMPACT Sacroiliac Joint Fixation System is manufactured by Life Spine, Inc..

What is the FDA product code for SIMPACT Sacroiliac Joint Fixation System?

The FDA product code for SIMPACT Sacroiliac Joint Fixation System is OUR.

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Other Devices by Life Spine, Inc.

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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. 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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