SkyWalker Total Knee System

510(k) Number

K213873 ↗

FDA product code

OLO

FDA applicant

Microport Navibot International, LLC

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).

• ExcelsiusGPS Spine 1.1 Interbody Module by GLOBUS MEDICAL, INC.
• Stealth AXiS Advanced Spine Referencing Kit SS 9736697 by Medtronic Navigation Inc.
• Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm System by Brainlab AG
• ROSA Knee System by Orthosoft Inc. (d/b/a) Zimmer CAS
• 9735522 by Medtronic Navigation Inc.
• CD HORIZON® Spinal System RBT033301 by MEDTRONIC SOFAMOR DANEK, INC.
• Consolidated Operating Room Equipment (CORE) 2 Console by Stryker Instruments
• CD HORIZON® Spinal System RBT033102 by MEDTRONIC SOFAMOR DANEK, INC.
• 6002-140-001 by Stryker Leibinger
• VADER Pedicle System, VADER Pedicle System Navigated Instruments, Container Base 42-700-1 by icotec AG

• 10034-Nb

  Class II

  FDA 510(k) K213873 Active Cleared 7 Jul 2022 GUDID on market

• B.B6.050-Nb

  Class II

  FDA 510(k) K213873 Active Cleared 7 Jul 2022 GUDID on market

• 10031-Nb

  Class II

  FDA 510(k) K213873 Active Cleared 7 Jul 2022 GUDID on market

• 10038-Nb

  Class II

  FDA 510(k) K213873 Active Cleared 7 Jul 2022 GUDID on market

See all devices from Microport Navibot International LLC →