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Orthopaedic Surgical Planning And Instrument Guides

Orthopaedic Surgical Planning And Instrument Guides is a medical device type in the Orthopedic specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.

Global Registration Data
Multi-Country Intelligence
Orthopaedic Surgical Planning And Instrument Guides
Orthopedic Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

PBF

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Class 2

21 CFR 888.3030

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Orthopedic

Device Characteristics

No

No

No

Not Eligible

Definition

As a surgical instrument to assist in pre-operative planning and/or guiding the marking of bone and/or guide surgical instruments for orthopedic surgical procedures.