← FDA Medical Device Classifications

Vertebral Body Tethering System

QHP · Not classified · Unknown

Classification

FDA Product Code
QHP
Device class
Not classified
Regulation
Review panel
OR
Medical specialty
Unknown
Submission type
6
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N

Definition

Anterior-based stabilization or correction of juvenile or adolescent idiopathic scoliosis without the use of fusion

Market data

Cleared 510(k) submissions
0
Registered establishments
8

Source

Authoritative
FDA Device Classification database
Machine
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