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Large Cannulated Screws 71119105

by Smith & Nephew, Inc.

Large Cannulated Screws 71119105 is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K123055 on 25 Jan 2013 and listed in FDA GUDID since 13 Nov 2017 (UDI-DI 03596010428363), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K123055

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03596010428363 UDI-DI Date13 Nov 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK123055 Date25 Jan 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K123055 decided 25 Jan 2013 Active
  • FDA GUDID UDI-DI 03596010428363 listed 13 Nov 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K123055
  2. Listed FDA GUDID 03596010428363

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Large Cannulated Screws
Generic name
Surgical drill guide, reusable
Model / Ref / Catalog
71119105
Primary DI / UDI-DI
03596010428363
510(k) Number
FDA product code
HRS
GMDN term
Surgical drill guide, reusable
Device class
Class II
Regulation number
888.3030
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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Properties

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