CONNECTOR 811179GR 90MM SS 3.5MM ROD S
CD HORIZON® Growth Rod Conversion Set - 811179GR
Device Description
An assembly of sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Sterile disposable devices associated with implantation may be included.
Environmental Conditions
No Data Available
Device Sizes
- DIA= 3.5mm L=90mm
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: PGM
Device Name: Growing Rod System
Device Class: 2
Physical State: Metalllic rods, monoaxial or polyaxial bone screws, hooks, and other related accessories.
Definition: Stabilization or correction of spinal deformities without the use of fusion.
Submission Type ID: 1
Review Panel: OR
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: The system of distracting or compressing rods and fixation elements (screws, hooks, etc.) provides stabilization and correction of the spine as the child grows.
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: Y
Target Area: Pediatric spine.
Regulation Number: 888.3070
Third Party Flag: N
Medical Specialty: OR
Device IdentifiersDevice Id: 00643169500648
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A