RESPONSE Navigation Instruments

510(k) Number

K203573 ↗

FDA product code

OLO

Device class

Class II

Regulation

21 CFR Part 882.4560

Advisory committee

Neurology

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code OLO (Orthopedic Stereotaxic Instrument).

• OMNIBotics NS-5016L by OMNIlife science, Inc.
• REAL INTELLIGENCE™ CORI™ by Blue Belt Technologies, Inc.
• Mako Total Hip Application, Mako Total Knee Application by MAKO Surgical Corp.
• OMNIBotics NV-CRD05 by OMNIlife science, Inc.
• Medtronic 9735283 by Medtronic Navigation Inc.
• Mazor X Spine Disposable Kit KIT0574-12 by MAZOR ROBOTICS LTD
• GX Navigation Instrument System by Life Spine, Inc.
• ROSA Partial Knee System by Orthosoft Inc. (d/b/a) Zimmer CAS
• 6002-050-000 by Stryker Leibinger
• Mako Partial Knee Application by MAKO Surgical Corp.

• Orthopediatrics® Locking Proximal Femur Plate System Distal Femoral Osteotomy System

  Class IIb

  CE/MDR

• Orthopediatrics® Instrumentation

  Class IIa

  CE/MDR

• Orthopediatrics® Pediloc™ Fragment System

  Class IIb

  CE/MDR

• Orthopediatrics® Pedinail™ Intramedullary Nailing System

  Class IIb

  CE/MDR

See all devices from Orthopediatrics Corp. →