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Uni-Thread® L2-C533T

by Spine Vision, Inc.

Uni-Thread® L2-C533T is a Class II device made by Spine Vision, Inc., cleared under FDA 510(k) K013301 on 13 Feb 2002 and listed in FDA GUDID since 15 Oct 2015 (UDI-DI 03663136004709), active as of 22 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 22 Oct 2026

Documents

510(k) K013301

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03663136004709 UDI-DI Date15 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK013301 Date13 Feb 2002DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K013301 decided 13 Feb 2002 Active
  • FDA GUDID UDI-DI 03663136004709 listed 15 Oct 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K013301
  2. Listed FDA GUDID 03663136004709

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Uni-Thread®
Generic name
Spinal bone screw, non-bioabsorbable
Model / reference
L2-C533T
Primary DI / UDI-DI
03663136004709
510(k) Number
FDA product code
MNI, MNH
GMDN term
Spinal bone screw, non-bioabsorbable
Device class
Class II
Regulation number
888.3070
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Spinal bone screw, non-bioabsorbable

Cleared under the same submission (K013301)

and 8 more cleared under K013301

Similar devices in this category

Other devices filed under Spinal bone screw, non-bioabsorbable.

Other devices from Spine Vision, Inc.

See all devices from Spine Vision, Inc. →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (10, all answered No)