Device type
Orthopedic Stereotaxic Instrument
Product code OLO · Class II · 21 CFR 882.4560 · Neurology
Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.
Recent 510(k)s
Oct 26, 2026
K262567
GPS Ankle
Blue Ortho
- OLO
- Class II
Oct 19, 2026
K260403
7D Surgical System (10-0001)
7D Surgical ULC
- OLO
- Class II
Oct 16, 2026
K263234
TMINI Miniature Robotic System
THINK Surgical, Inc.
- OLO
- Class II
Oct 9, 2026
K263154
CarboClear® Cervical Navigated Instruments
CarboFix Orhtopedics , Ltd.
- OLO
- Class II
Sep 30, 2026
K262257
Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine
Brainlab SE
- OLO
- Class II
Aug 20, 2026
K262506
Remex Spine Surgery Navigation - Universal Instruments
Remex Medical Corp.
- OLO
- Class II
Recent recalls
Oct 28, 2026
Z-0192-2027
Think Surgical Square Driver REF: 109126
Think Surgical, Inc.
- OLO
- Class II
- Ongoing
Oct 14, 2026
Z-0119-2027
Intellijoint Navigation System: Workstation G2 Configured, REF: 000-0241; Intellijoint HIP Cart System, REF: 000-0250; Intellijoint HIP, Portable System, REF:…
Intellijoint Surgical, Inc.
- OLO
- Class II
- Ongoing
Sep 9, 2026
Z-3088-2026
Velys Enabling Tech Robotic-Assist Station REF: 451611001
Medos International Sarl
- OLO
- Class II
- Ongoing