FDA UDI
In Commercial Distribution
🇺🇸 United States
Polaris 5.5 Spinal Fixation System
DI: 03662663182867
·
Model: 2000-1008
·
Highridge Medical, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Polaris 5.5 Spinal Fixation System
- Primary DI
- 03662663182867
- Version / Model
- 2000-1008
- Catalog Number
- 2000-1008
- Company Name
- Highridge Medical, LLC
- Labeler DUNS
- 119260394
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-21
- Public Version
- 1
- Public Version Date
- 2025-12-01
- Public Version Status
- New
- Public Device Record Key
- 9b1db4cb-4165-44e7-8b5a-022ab52e3e46
Device Description
DEROTATION PLUG 5.5
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NKB | Thoracolumbosacral pedicle screw system | Orthopedic | 888.3070 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65553 | Spinal bone set screw | A small, implantable, non-bioabsorbable disc, threaded on its outside surface, intended to be threaded into the internal proximal end of a spinal bone screw head/rod adaptor, anchor, connector and/or hook (none included) to secure/stabilize a rod and/or tether as part of an internal spinal fixation procedure or a treatment for idiopathic scoliosis. It is made of metal (e.g., surgical steel, titanium alloy). | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03662663182867 | GS1 |
Customer Contacts
- Phone
- +1(800)447-3625
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Device Size Text, specify---DEROTATION PLUG 5.5 |