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NexFix NCS-OB45

by Tornier, Inc.

NexFix NCS-OB45 is a Class I device made by Tornier, Inc., listed in FDA GUDID since 10 Aug 2022 (UDI-DI 00846832018444), 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 Number00846832018444 UDI-DI Date10 Aug 2022ListedStatusListed 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  • Withdrawn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
NexFix
Generic name
Surgical drill guide obturator
Model / Ref / Catalog
NCS-OB45
Primary DI / UDI-DI
00846832018444
FDA product code
LXH
GMDN term
Surgical drill guide obturator
Device class
Class I
Regulation number
888.4540
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Other devices from Tornier, Inc.

See all devices from Tornier, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (11, all answered No)