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BLACKBIRD Spinal System LT40-P025

by Choicespine, LP

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840996174343 UDI-DI Date18 Aug 2018ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
BLACKBIRD Spinal System
Generic name
Bone-screw internal spinal fixation system rod
Model / reference
LT40-P025
Primary DI / UDI-DI
00840996174343
510(k) Number
FDA product code
KWP
GMDN term
Bone-screw internal spinal fixation system rod
Device class
Class II
Regulation number
888.3050
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Length — 25 Millimeter
Outer Diameter — 3.5 Millimeter

Related devices

Category: Bone-screw internal spinal fixation system rod

Cleared under the same submission (K133214)

Show all (12)

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Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number

Other properties (10)

  • Supplied sterile: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No