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FDA 510(k)

S-COMP Reform® POCT Navigation Instruments

K-Number: K231229 · 2023-05-25

ApplicantPrecision Spine, Inc.
Decision Date2023-05-25
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

S-COMP Reform® POCT Navigation Instruments is a medical device manufactured by Precision Spine, Inc.. It received FDA 510(k) clearance on 2023-05-25 under approval number K231229. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S-COMP Reform® POCT Navigation Instruments?

S-COMP Reform® POCT Navigation Instruments is a medical device that received FDA 510(k) clearance on 2023-05-25. It is manufactured by Precision Spine, Inc.. The 510(k) number is K231229.

When was S-COMP Reform® POCT Navigation Instruments approved by the FDA?

S-COMP Reform® POCT Navigation Instruments received FDA 510(k) clearance on 2023-05-25, under approval number K231229.

What company makes S-COMP Reform® POCT Navigation Instruments?

S-COMP Reform® POCT Navigation Instruments is manufactured by Precision Spine, Inc..

What is the FDA product code for S-COMP Reform® POCT Navigation Instruments?

The FDA product code for S-COMP Reform® POCT Navigation Instruments is OLO.

Related Clinical Trials

NCT07518615 Clinical Safety and Effectiveness of the Straumann Dynamic Navigation System Falcon RECRUITING

Other Devices by Precision Spine, Inc.

K161809ShurFit CpTi-HA ACIF Interbody Fusion System K162211AccuFit Lateral Plate System K162300Reform® POCT System K160568Precision Spine Interspinous Plate System K173130Reform® Midline Cortical Screw System K171657ShurFit 2C Lumbar Interbody Fusion System

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Related Devices (Code: OLO)

K162375Envision 3D: Image Guidance System7D Surgical, Inc. K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc. K160385Precision ScrewCryptych Pty, Ltd. K153700Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC K153240Styrker OrthoMap Express Knee SystemStryker Corporate

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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