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IntraLock TN-IL-5034

by Fusion Orthopedics, LLC 2 variants

IntraLock TN-IL-5034 is a Class II device made by Fusion Orthopedics, LLC, listed in FDA GUDID since 14 May 2025 (UDI-DI 00840124519152), registry data as of 23 Oct 2026.

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840124519152 UDI-DI Date14 May 2025ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
IntraLock
Generic name
Orthopaedic implantation sleeve, single-use
Model / Ref / Catalog
TN-IL-5034
Primary DI / UDI-DI
00840124519152
FDA product code
NJA
GMDN term
Orthopaedic implantation sleeve, single-use
Device class
Class II
Regulation number
888.3040
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic implantation sleeve, single-use

Similar devices in this category

Other devices filed under Orthopaedic implantation sleeve, single-use.

Other devices from Fusion Orthopedics USA, LLC

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    Class II

  • FibFix FN-TH-4713

    Class II

  • FibFix FN-TH-5713

    Class II

  • FibFix FN-TH-5713-S

    Class II

See all devices from Fusion Orthopedics USA, LLC →

Properties

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