Cleared Special

S-COMP Reform? POCT Navigation Instruments

K231229 · Precision Spine, Inc. · Orthopedic

May 2023

Decision

27d

Days

Class 2

Risk

About This 510(k) Submission

K231229 is an FDA 510(k) clearance for the S-COMP Reform? POCT Navigation Instruments, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by Precision Spine, Inc. (Pear, US). The FDA issued a Cleared decision on May 25, 2023, 27 days after receiving the submission on April 28, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K231229 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 28, 2023
Decision Date	May 25, 2023
Days to Decision	27 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OLO — Orthopedic Stereotaxic Instrument
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.4560
Definition	Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw.