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SAGICO OSI Spinal System

by Spinal Analytics & Geometrical Implant Co, LLC

510(k) K180220

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK180220 Date21 May 2018ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
SAGICO OSI Spinal System by Osimplant
510(k) Number
FDA Product Code
NKB
Device Class
Class II
Regulation
21 CFR Part 888.3070
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The SAGICO OSI Spinal System is a spinal implant device designed for orthopedic applications. It is classified under product code NKB and is intended for use in spinal surgical procedures, providing structural support and stabilization to the spine.

This system is supplied by Spinal Analytics & Geometrical Implant Co, LLC, and has received FDA 510(k) clearance under the Traditional pathway. The device is intended for single-use, as indicated by its regulatory submission, and is regulated under the Orthopedic advisory committee. No additional details regarding sterility, MRI safety, or specific storage conditions are provided in the submitted data.

Other devices from Spinal Analytics & Geometrical Impant Co, LLC

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of spinal surgical procedures is the SAGICO OSI Spinal System intended for?

    The SAGICO OSI Spinal System is designed to provide structural support and stabilization during orthopedic spinal surgical procedures. It falls under product code NKB, which typically includes spinal fixation devices used to address instability, deformity, or degenerative conditions requiring surgical intervention.

  • Is the SAGICO OSI Spinal System intended for reuse or single-use?

    The SAGICO OSI Spinal System is indicated for single-use, as explicitly stated in its regulatory submission to the FDA. This designation aligns with common practices for spinal implants to ensure patient safety and sterility.

  • How was the FDA clearance for the SAGICO OSI Spinal System determined?

    The SAGICO OSI Spinal System received FDA 510(k) clearance under the Traditional pathway, with a decision described as ‘Substantially Equivalent’ (SESE). This means the FDA determined it is as safe and effective as a legally marketed device that served as its predicate.

  • Who is the manufacturer of the SAGICO OSI Spinal System, and where can inquiries be directed?

    The manufacturer is Spinal Analytics & Geometrical Implant Co, LLC, based at 2189 W. Busch Blvd., Tampa, FL 33612. For inquiries, you may contact James J. Gibson Jr., though specific contact methods (e.g., email, phone) are not provided in the available data.