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EF1 Dne-12-B

by Medshape, Inc.

EF1 Dne-12-B is a Class II device made by Medshape, Inc., cleared under FDA 510(k) K113106 on 4 Jan 2012 and listed in FDA GUDID since 31 May 2024 (UDI-DI 00810028397149), 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) K113106

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 Number00810028397149 UDI-DI Date31 May 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK113106 Date4 Jan 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K113106 decided 4 Jan 2012 Active
  • FDA GUDID UDI-DI 00810028397149 listed 31 May 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K113106
  2. Listed FDA GUDID 00810028397149

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
EF1
Generic name
External orthopaedic fixation system noninvasive component, single-use
Model / reference
DNE-12-B
Primary DI / UDI-DI
00810028397149
510(k) Number
FDA product code
KTT
GMDN term
External orthopaedic fixation system noninvasive component, single-use
Device class
Class II
Regulation number
888.3030
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
MRI safety
MR Unsafe

Related devices

Category: External orthopaedic fixation system noninvasive component, single-use

Cleared under the same submission (K113106)

and 8 more cleared under K113106

Similar devices

Other devices filed under FDA product code KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component).

Other devices from Medshape, Inc.

See all devices from Medshape, Inc. →

Properties

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