FDA product code OJB

Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate

Orthopedic·Class 2·21 CFR 888.3060·Implantable
US regulatory classifications
US Product Code (FDA)
OJB
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 888.3060
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Medical specialty
Orthopedic
Device characteristics
GMP exempt
No
Implantable
Yes
Life-sustaining
No
Third party review
Not Eligible
Definition

Maintain position of bone graft in spinal fusion procedures. Intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts, in conjunction with traditional rigid fixation.

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About this record

Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate 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. This device type includes implantable products.

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.