Skip to content

03.010.435

by Synthes GmbH

03.010.435 (03010435) is a Class II device made by Synthes GmbH, cleared under FDA 510(k) K111667 on 5 Dec 2011 and listed in FDA GUDID since 14 Sep 2015 (UDI-DI 10886982068767), active as of 12 Nov 2026. One FDA recall is linked to it.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K111667

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10886982068767 UDI-DI Date14 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK111667 Date5 Dec 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K111667 decided 5 Dec 2011 Active
  • FDA GUDID UDI-DI 10886982068767 listed 14 Sep 2015 Listed

Recalls

1 recall · FDA

    • Terminated Z-0404-2014 FDA Class II initiated 14 Oct 2013

    Complaints were received reporting that a product packaged as a 14.5 mm Outer Protection Sleeve for Suprapatellar contained a 12.0 mm Outer Protection Sleeve for Suprapatellar.

Timeline

3 dated events

  1. Cleared FDA 510(k) K111667
  2. Recall initiated FDA recalls Z-0404-2014
  3. Listed FDA GUDID 10886982068767

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Orthopaedic implantation sleeve, reusable
Model / Ref / Catalog
03.010.435, 03010435
Primary DI / UDI-DI
10886982068767
510(k) Number
FDA product code
JDS
GMDN term
Orthopaedic implantation sleeve, reusable
Device class
Class II
Regulation number
888.3030
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic implantation sleeve, reusable

Cleared under the same submission (K111667)

and 8 more cleared under K111667

Similar devices in this category

Other devices filed under Orthopaedic implantation sleeve, reusable.

Other devices from Synthes GmbH

  • Tomofix

    Class IIb

  • 03.111.100S

    Class IIb

  • 68.134.011

    Class II

  • Volt 68.134.111

    Class II

See all devices from Synthes GmbH →

Properties

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