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Tensioner, Sizer 2120.00.000

by Enztec Limited

Tensioner, Sizer 2120.00.000 is a Class I device made by Enztec Limited, listed in FDA GUDID since 3 Sep 2026 (UDI-DI 09421028119801), 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 Number09421028119801 UDI-DI Date3 Sep 2026ListedStatusListed 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  • Withdrawn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
Tensioner, Sizer
Generic name
Orthopaedic prosthesis implantation positioning instrument, reusable
Model / Ref / Catalog
2120.00.000
Primary DI / UDI-DI
09421028119801
FDA product code
LXH
GMDN term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device class
Class I
Regulation number
888.4540
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Similar devices

Other devices filed under FDA product code LXH (Orthopedic Manual Surgical Instrument).

Other devices from Enztec Limited

See all devices from Enztec Limited →

Properties

  • Sterilise before use
  • Premarket exempt
  • Lot / batch number
Other properties (12, all answered No)