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THUNDERBOLT Minimally Invasive Pedicle Screw Systems MT10-12530

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 Number00840996148849 UDI-DI Date23 Feb 2017ListedStatusListed 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  • Withdrawn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
Spinal bone screw, non-bioabsorbable
Model / Reference
MT10-12530
Primary DI / UDI-DI
00840996148849
510(k) Number
FDA Product Code
MNH, NKB, MNI
GMDN Term
Spinal bone screw, non-bioabsorbable
Device Class
Class II
Regulation Number
888.3070
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Outer Diameter — 12.5 Millimeter
Length — 30 Millimeter

Related devices

Category: Spinal bone screw, non-bioabsorbable

Cleared under the same submission (K132049)

Show all (12)

Other devices from Choicespine, LP

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Properties

  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number

Other properties (10)

  • 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