Last synced on 25 April 2025 at 11:05 pm

Posterior Ratcheting Rod System

Page Type
Product Code
Definition
Stabilization or correction of adolescent idiopathic scoliosis without the use of fusion.
Physical State
Metallic ratcheting rod, pedicle screws, and other related accessories.
Technical Method
The system of a ratcheting rod and fixation elements (e.g., pedicle screws) provides 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 QGP is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.

Posterior Ratcheting Rod System

Page Type
Product Code
Definition
Stabilization or correction of adolescent idiopathic scoliosis without the use of fusion.
Physical State
Metallic ratcheting rod, pedicle screws, and other related accessories.
Technical Method
The system of a ratcheting rod and fixation elements (e.g., pedicle screws) provides 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 QGP is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.