Last synced on 25 April 2025 at 11:05 pm

Vertebral Body Tethering System

Page Type
Product Code
Definition
Anterior-based stabilization or correction of juvenile or adolescent idiopathic scoliosis without the use of fusion
Physical State
Polymeric flexible cord, metallic bone screws, and other related accessories
Technical Method
The system of a flexible cord and fixation elements (e.g., bone screws) to provide stabilization or correction of the spine
Target Area
Pediatric spine
Review Panel
Orthopedic
Submission Type
HDE - Humanitarian Device Exemption
Device Classification
N
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

As product code QHP is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.

Vertebral Body Tethering System

Page Type
Product Code
Definition
Anterior-based stabilization or correction of juvenile or adolescent idiopathic scoliosis without the use of fusion
Physical State
Polymeric flexible cord, metallic bone screws, and other related accessories
Technical Method
The system of a flexible cord and fixation elements (e.g., bone screws) to provide stabilization or correction of the spine
Target Area
Pediatric spine
Review Panel
Orthopedic
Submission Type
HDE - Humanitarian Device Exemption
Device Classification
N
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

As product code QHP is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.