Arcadis Ordic (Available with Options 3D and 3D Navigation Interface)

• • Terminated Z-0438-06 FDA Unclassified (pre-2012) ·initiated 12 Dec 2005 ·on shared 510(k) K042793

  patient information can be stored in another patient's file.

• • Terminated Z-0118-06 FDA Unclassified (pre-2012) ·initiated 1 Aug 2005 ·on shared 510(k) K042793

  Screws may become loose and fall into the OR field during surgery.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K042793 ↗

FDA Product Code

OWB

Device Class

Class II

Regulation

21 CFR Part 892.1650

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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• MOBILETT Impact

  Class II

  FDA 510(k) K231577 Active Cleared 25 Jul 2023

See all devices from Siemens Medi Cal Solutions, Inc. →