Instruments Designed For Press-Fit Osteochondral Implants

QBO · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.4505

Classification

FDA Product Code: QBO
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 888.4505
Review panel: OR
Medical specialty: Orthopedic
Submission type: 4
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

The device is intended to manipulate bone and cartilage tissue or implant materials for the positioning, alignment, defect creation, or placement of press-fit osteochondral implants.

Market data

Cleared 510(k) submissions: 2
Registered establishments: 14

Source

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