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Simpact 152-12-9401

by Life Spine, Inc.

Simpact 152-12-9401 is a Class II device made by Life Spine, Inc., cleared under FDA 510(k) K141246 on 22 Feb 2015 and listed in FDA GUDID since 23 Nov 2021 (UDI-DI 00190837146658), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K141246

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00190837146658 UDI-DI Date23 Nov 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK141246 Date22 Feb 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K141246 decided 22 Feb 2015 Active
  • FDA GUDID UDI-DI 00190837146658 listed 23 Nov 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K141246
  2. Listed FDA GUDID 00190837146658

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Simpact
Generic name
Trans-facet-screw internal spinal fixation system, sterile
Model / reference
152-12-9401
Primary DI / UDI-DI
00190837146658
510(k) Number
FDA product code
OUR
GMDN term
Trans-facet-screw internal spinal fixation system, sterile
Device class
Class II
Regulation number
888.3040
GUDID distribution status
In Commercial Distribution
Sterilisation method
Radiation Sterilization

Related devices

Category: Trans-facet-screw internal spinal fixation system, sterile

Cleared under the same submission (K141246)

and 8 more cleared under K141246

Other devices from Life Spine, Inc.

  • Arx 13-5550-13

    Class II

  • Arx 13-6540-13

    Class II

  • Arx 13-6550-13

    Class II

  • Arx 13-5545-13

    Class II

See all devices from Life Spine, Inc. →

Properties

  • Supplied sterile
  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)