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Uni-T Spinal System

by Spine Vision, Inc.

510(k) K013301

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK013301 Date13 Feb 2002ClearedStatusActive

Official records

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  • Withdrawn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

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

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 UNI-T Uni-Thread Spinal System is a posterior spinal fixation device classified as an orthopedic spinal fixation system. It consists of titanium alloy screws, rods, and connectors designed to immobilize and stabilize spinal segments during surgical fusion procedures, addressing pathologies such as deformities and instability in the thoracic, lumbar, and sacral spine.

This system is assembled into customizable constructs for implantation during surgery and is supplied as a reusable surgical instrument set. Components are manufactured from titanium alloy per ASTM F136 standards and are intended for single-use implantation. The device holds FDA 510(k) clearance under the traditional review pathway, with a product code of MNI, and is intended for use in orthopedic spinal procedures.

Devices cleared under K013301

118 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K013301
UDI-DISize and differences
UNI-THREAD® L2-C533T
Spine Vision, Inc.
L2-C533T03663136004709 —On the market
UNI-THREAD® L2-C548T
Spine Vision, Inc.
L2-C548T03663136004730 —On the market
UNI-THREAD® L2-C628T
Spine Vision, Inc.
L2-C628T03663136004761 —On the market
UNI-THREAD® L2-C633T
Spine Vision, Inc.
L2-C633T03663136004778 —On the market
UNI-THREAD® L2-C638T
Spine Vision, Inc.
L2-C638T03663136004785 —On the market
UNI-THREAD® L2-C653T
Spine Vision, Inc.
L2-C653T03663136004815 —On the market
UNI-THREAD® L2-C658T
Spine Vision, Inc.
L2-C658T03663136004822 —On the market
UNI-THREAD® L2-C738T
Spine Vision, Inc.
L2-C738T03663136004853 —On the market
UNI-THREAD® L2-C743T
Spine Vision, Inc.
L2-C743T03663136004860 —On the market
UNI-THREAD® L2-C828T
Spine Vision, Inc.
L2-C828T03663136004907 —On the market
UNI-THREAD® L2-C838T
Spine Vision, Inc.
L2-C838T03663136004921 —On the market
UNI-THREAD® L2-C853T
Spine Vision, Inc.
L2-C853T03663136004952 —On the market
UNI-THREAD® L2-C858T
Spine Vision, Inc.
L2-C858T03663136004969 —On the market
UNI-THREAD® L2-CH533T
Spine Vision, Inc.
L2-CH533T03663136004990 —On the market
UNI-THREAD® L2-CH548T
Spine Vision, Inc.
L2-CH548T03663136005027 —On the market
UNI-THREAD® L2-CH553T
Spine Vision, Inc.
L2-CH553T03663136005034 —On the market
UNI-THREAD® L2-CH558T
Spine Vision, Inc.
L2-CH558T03663136005041 —On the market
UNI-THREAD® L2-L165T
Spine Vision, Inc.
L2-L165T03663136005218 —On the market
UNI-THREAD® L2-L175T
Spine Vision, Inc.
L2-L175T03663136005225 —On the market
UNI-THREAD® L2-L665T
Spine Vision, Inc.
L2-L665T03663136005263 —On the market
UNI-THREAD® L2-L855T
Spine Vision, Inc.
L2-L855T03663136005270 —On the market
UNI-THREAD® L2-L875T
Spine Vision, Inc.
L2-L875T03663136005294 —On the market
UNI-THREAD® L2-L965T
Spine Vision, Inc.
L2-L965T03663136005317 —On the market
UNI-THREAD® L2-L975T
Spine Vision, Inc.
L2-L975T03663136005324 —On the market
UNI-THREAD® L2-LSPL175T
Spine Vision, Inc.
L2-LSPL175T03663136005348 —On the market
UNI-THREAD® L2-R604CHT
Spine Vision, Inc.
L2-R604CHT03663136005461 —On the market
UNI-THREAD® L2-R605T
Spine Vision, Inc.
L2-R605T03663136005515 —On the market
UNI-THREAD® L2-R606T
Spine Vision, Inc.
L2-R606T03663136005546 —On the market
UNI-THREAD® L2-R609CHT
Spine Vision, Inc.
L2-R609CHT03663136005614 —On the market
UNI-THREAD® L2-R609HT
Spine Vision, Inc.
L2-R609HT03663136005621 —On the market
UNI-THREAD® L2-R610CHT
Spine Vision, Inc.
L2-R610CHT03663136005645 —On the market
UNI-THREAD® L2-R610T
Spine Vision, Inc.
L2-R610T03663136005669 —On the market
UNI-THREAD® L2-R612CHT
Spine Vision, Inc.
L2-R612CHT03663136005676 —On the market
UNI-THREAD® L2-R612T
Spine Vision, Inc.
L2-R612T03663136005690 —On the market
UNI-THREAD® L2-R614T
Spine Vision, Inc.
L2-R614T03663136005720 —On the market
UNI-THREAD® L2-R625T
Spine Vision, Inc.
L2-R625T03663136005799 —On the market
UNI-THREAD® L2-S643T
Spine Vision, Inc.
L2-S643T03663136006093 —On the market
UNI-THREAD® L2-S650T
Spine Vision, Inc.
L2-S650T03663136019024 —On the market
UNI-THREAD® L2-S653T
Spine Vision, Inc.
L2-S653T03663136006116 —On the market
UNI-THREAD® L2-S728T
Spine Vision, Inc.
L2-S728T03663136006130 —On the market
UNI-THREAD® L2-S748T
Spine Vision, Inc.
L2-S748T03663136006178 —On the market
UNI-THREAD® L2-S758T
Spine Vision, Inc.
L2-S758T03663136006192 —On the market
UNI-THREAD® L2-SH538T
Spine Vision, Inc.
L2-SH538T03663136006222 —On the market
UNI-THREAD® L2-SH543T
Spine Vision, Inc.
L2-SH543T03663136006239 —On the market
UNI-THREAD® L2-SH558T
Spine Vision, Inc.
L2-SH558T03663136006260 —On the market
UNI-THREAD® L2-T613T
Spine Vision, Inc.
L2-T613T03663136006284 —On the market
UNI-THREAD® L2-T620T
Spine Vision, Inc.
L2-T620T03663136006307 —On the market
UNI-THREAD® L2-T641T
Spine Vision, Inc.
L2-T641T03663136006376 —On the market
UNI-THREAD® L2-T659T
Spine Vision, Inc.
L2-T659T03663136006437 —On the market
UNI-THREAD® L2-T662T
Spine Vision, Inc.
L2-T662T03663136006444 —On the market

Similar devices

Other devices filed under FDA product code MNI (Orthosis, Spinal Pedicle Fixation).

Other devices from Spine Vision, Inc.

See all devices from Spine Vision, Inc. →