Skip to content

BOLT, Ti6Al4V, 7.0mm x 80-100mm, 5mm HEX 104-0156-01

by Ortho Outcomes, LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850072364032 UDI-DI Date28 Feb 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
BOLT, Ti6Al4V, 7.0mm x 80-100mm, 5mm HEX
Generic Name
Orthopaedic bone bolt
Model / Reference
104-0156-01
Primary DI / UDI-DI
00850072364032
FDA Product Code
HWC
GMDN Term
Orthopaedic bone bolt
Device Class
Class II
Regulation Number
888.3040
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Other devices from Ortho Outcomes, LLC

See all devices from Ortho Outcomes, LLC →

Properties

  • Single Use
  • Implantable
  • Convenience Kit
  • Lot / Batch Number

Other properties (10)

  • Sterile: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No