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TAURUS Pedicle Screw System 51-1000-002

by CTL Medical Corporation

TAURUS Pedicle Screw System 51-1000-002 is a Class II device made by CTL Medical Corporation, cleared under FDA 510(k) K162160 on 18 Nov 2016 and listed in FDA GUDID since 15 Sep 2023 (UDI-DI 00841732149854), 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) K162160

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 Number00841732149854 UDI-DI Date15 Sep 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK162160 Date18 Nov 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K162160 decided 18 Nov 2016 Active
  • FDA GUDID UDI-DI 00841732149854 listed 15 Sep 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K162160
  2. Listed FDA GUDID 00841732149854

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
TAURUS Pedicle Screw System
Generic name
Spinal bone screw head/rod adaptor
Model / reference
51-1000-002
Primary DI / UDI-DI
00841732149854
510(k) Number
FDA product code
KWP, MNH, MNI, NKB
GMDN term
Spinal bone screw head/rod adaptor
Device class
Class II
Regulation number
888.3050, 888.3070
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Similar devices

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

Other devices from CTL Medical Corporation

See all devices from CTL Medical Corporation →

Properties

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