Orthopaedic Surgical Planning And Instrument Guides

PBF · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.3030

Classification

FDA Product Code: PBF
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 888.3030
Review panel: OR
Medical specialty: Orthopedic
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 27
Registered establishments: 34

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown