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Plus Pivot Link Universal System

by Spine Vision, Inc. 4 variants

510(k) K021507

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 NumberK021507 Date1 Aug 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  • Withdrawn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
KWP
Device class
Class II
Regulation
21 CFR Part 888.3050
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 Plus Pivot Link Universal System is a spinal instrumentation set comprising hooks, screws, rods, and connectors that surgeons assemble into constructs tailored to specific spinal pathologies. It provides mechanical immobilization to facilitate fusion in acute or chronic spinal instabilities.

The system is used in clinical or operating room settings for posterior spinal fixation and stabilization. It is supplied as a universal system with various components for assembly. The device has FDA 510(k) clearance with number K021507.

Devices cleared under K021507

179 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 K021507
UDI-DISize and differences
P.L.U.S.® U1 - R604HT
Spine Vision, Inc.
U1 - R604HT03663136016702 —On the market
P.L.U.S.® U1 - R605HT
Spine Vision, Inc.
U1 - R605HT03663136016733 —On the market
P.L.U.S.® U1 - R605T
Spine Vision, Inc.
U1 - R605T03663136022253 —On the market
P.L.U.S.® U1 - R606T
Spine Vision, Inc.
U1 - R606T03663136022260 —On the market
P.L.U.S.® U1 - R610HT
Spine Vision, Inc.
U1 - R610HT03663136016887 —On the market
P.L.U.S.® U1 - R614HT
Spine Vision, Inc.
U1 - R614HT03663136016931 —On the market
P.L.U.S.® U1 - R615HT
Spine Vision, Inc.
U1 - R615HT03663136021249 —On the market
P.L.U.S.® U1 - R617HT
Spine Vision, Inc.
U1 - R617HT03663136021263 —On the market
P.L.U.S.® U1 - R618T
Spine Vision, Inc.
U1 - R618T03663136022383 —On the market
P.L.U.S.® U1 - R625HT
Spine Vision, Inc.
U1 - R625HT03663136021348 —On the market
P.L.U.S.® U1 - R628T
Spine Vision, Inc.
U1 - R628T03663136022482 —On the market
P.L.U.S.® U1 - R631T
Spine Vision, Inc.
U1 - R631T03663136022512 —On the market
P.L.U.S.® U1 - R632T
Spine Vision, Inc.
U1 - R632T03663136022529 —On the market
P.L.U.S.® U1 - R633T
Spine Vision, Inc.
U1 - R633T03663136022536 —On the market
P.L.U.S.® U1 - R634T
Spine Vision, Inc.
U1 - R634T03663136022543 —On the market
P.L.U.S.® U1 - R635HT
Spine Vision, Inc.
U1 - R635HT03663136021447 —On the market
P.L.U.S.® U1 - R638T
Spine Vision, Inc.
U1 - R638T03663136022581 —On the market
P.L.U.S.® U1 - R642T
Spine Vision, Inc.
U1 - R642T03663136022628 —On the market
P.L.U.S.® U1 - R644HT
Spine Vision, Inc.
U1 - R644HT03663136021522 —On the market
P.L.U.S.® U1 - R645HT
Spine Vision, Inc.
U1 - R645HT03663136021539 —On the market
P.L.U.S.® U1 - R645T
Spine Vision, Inc.
U1 - R645T03663136022659 —On the market
P.L.U.S.® U1 - R647HT
Spine Vision, Inc.
U1 - R647HT03663136021553 —On the market
P.L.U.S.® U1 - R648T
Spine Vision, Inc.
U1 - R648T03663136022680 —On the market
P.L.U.S.® U1 - R649HT
Spine Vision, Inc.
U1 - R649HT03663136021577 —On the market
P.L.U.S.® U1 - R651HT
Spine Vision, Inc.
U1 - R651HT03663136021584 —On the market
P.L.U.S.® U1 - R652HT
Spine Vision, Inc.
U1 - R652HT03663136021591 —On the market
P.L.U.S.® U1 - R654HT
Spine Vision, Inc.
U1 - R654HT03663136021614 —On the market
P.L.U.S.® U1 - R655HT
Spine Vision, Inc.
U1 - R655HT03663136021621 —On the market
P.L.U.S.® U1 - R655T
Spine Vision, Inc.
U1 - R655T03663136022758 —On the market
P.L.U.S.® U1 - R656T
Spine Vision, Inc.
U1 - R656T03663136022765 —On the market
P.L.U.S.® U1 - R657HT
Spine Vision, Inc.
U1 - R657HT03663136021645 —On the market
P.L.U.S.® U1 - R658HT
Spine Vision, Inc.
U1 - R658HT03663136021652 —On the market
P.L.U.S.® U1 - R660T
Spine Vision, Inc.
U1 - R660T03663136022802 —On the market
P.L.U.S.® U1-H202T
Spine Vision, Inc.
U1-H202T03663136014678 —On the market
P.L.U.S.® U1-H203T
Spine Vision, Inc.
U1-H203T03663136014692 —On the market
P.L.U.S.® U1-H30LT
Spine Vision, Inc.
U1-H30LT03663136014814 —On the market
P.L.U.S.® U1-H31RT
Spine Vision, Inc.
U1-H31RT03663136014876 —On the market
P.L.U.S.® U1-S425T
Spine Vision, Inc.
U1-S425T03663136017174 —On the market
P.L.U.S.® U1-S430
Spine Vision, Inc.
U1-S43003663136017181 —On the market
P.L.U.S.® U1-S435
Spine Vision, Inc.
U1-S43503663136017204 —On the market
P.L.U.S.® U1-S435T
Spine Vision, Inc.
U1-S435T03663136017211 —On the market
P.L.U.S.® U1-S445
Spine Vision, Inc.
U1-S44503663136017242 —On the market
P.L.U.S.® U1-S535T
Spine Vision, Inc.
U1-S535T03663136017334 —On the market
P.L.U.S.® U1-S540T
Spine Vision, Inc.
U1-S540T03663136017358 —On the market
P.L.U.S.® U1-S550T
Spine Vision, Inc.
U1-S550T03663136017396 —On the market
P.L.U.S.® U1-S635T
Spine Vision, Inc.
U1-S635T03663136017457 —On the market
P.L.U.S.® U1-S650T
Spine Vision, Inc.
U1-S650T03663136017518 —On the market
P.L.U.S.® U1-S655T
Spine Vision, Inc.
U1-S655T03663136017532 —On the market
P.L.U.S.® U1-S725T
Spine Vision, Inc.
U1-S725T03663136017570 —On the market
P.L.U.S.® U1-S790T
Spine Vision, Inc.
U1-S790T03663136017839 —On the market

Similar devices

Other devices filed under FDA product code KWP (Appliance, Fixation, Spinal Interlaminal).

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