Skip to content

THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems MT50-9565

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 Number00840996114486 UDI-DI Date24 Oct 2015ListedStatusListed 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  • Withdrawn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
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems
Generic Name
Bone-screw internal spinal fixation system, non-sterile
Model / Reference
MT50-9565
Primary DI / UDI-DI
00840996114486
510(k) Number
FDA Product Code
MNH, MNI, NKB
GMDN Term
Bone-screw internal spinal fixation system, non-sterile
Device Class
Class II
Regulation Number
888.3070
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Outer Diameter — 9.5 Millimeter
Length — 65 Millimeter

Related devices

Category: Bone-screw internal spinal fixation system, non-sterile

Cleared under the same submission (K132049)

Show all (12)

Other devices from Choicespine, LP

See all devices from Choicespine, LP →

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number

Other properties (11)

  • Sterile: No
  • Implantable: 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