K2M Navigation Instruments
by K2m 2 variants
510(k) K171556
K2M Navigation Instruments is a Class II device made by K2m, cleared under FDA 510(k) K171556 on 16 Jan 2018, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK171556 | Date16 Jan 2018 | StatusActive |
Official records
- FDA 510(k) database K171556
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OLO
- Device class
- Class II
- Regulation
- 21 CFR Part 882.4560
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code OLO (Orthopedic Stereotaxic Instrument).
- 6007-300-000 by Stryker Leibinger
- Total Knee Application (TKA) by MAKO Surgical Corp.
- Spine Planning (3.0) by Brainlab SE
- CoreLink Navigation Instruments by CORELINK LLC
- ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-HIP by MAKO Surgical Corp.
- CD HORIZON® Spinal System RBT043301 by MEDTRONIC SOFAMOR DANEK, INC.
- NAVITRACK SYSTEM - OS KNEE UNIVERSAL, CAS SAME INCISION TIBIA REFERENCE by Zimmer CAS
- Zimmer Biomet Universal Navigation System by Zimmer Biomet Spine, Inc.
- CD HORIZON® SOLERA® Spinal System 54850017540 by MEDTRONIC SOFAMOR DANEK, INC.
- Blueprint Mixed Reality system by Tornier S.A.S.