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Reform Pedicle Screw System

by Spinal USA 3 variants

510(k) K121172

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 · Special NumberK121172 Date8 Aug 2012ClearedStatusActive

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  • Withdrawn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)

510(k) Number
FDA Product Code
MNI
Device Class
Class II
Regulation
21 CFR Part 888.3070
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 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 Reform Pedicle Screw System is a spinal fixation device intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. It is used in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine, including degenerative spondylolisthesis with objective evidence of instability.

The device is supplied non-sterile and requires sterilization prior to use. It is intended for single-use application in surgical settings. Authorization for marketing in the United States was obtained via FDA 510(k) clearance (K121172) under product code MNI, with a determination of substantial equivalence to a predicate device.

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Questions

AI-generated answers, 28 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 is the Reform Pedicle Screw System used for?

    The Reform Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. It is used in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine, including degenerative spondylolisthesis with objective evidence of instability.

  • How is the Reform Pedicle Screw System supplied and prepared for use?

    The device is supplied non-sterile and requires sterilization prior to use. It is intended for single-use application in surgical settings, meaning it should not be reprocessed or reused after a surgical procedure.

  • What regulatory pathway was used to market the Reform Pedicle Screw System in the United States?

    Authorization for marketing in the United States was obtained via FDA 510(k) clearance (K121172) under product code MNI, with a determination of substantial equivalence to a predicate device.