FDA UDI
In Commercial Distribution
🇺🇸 United States
YUKON OCT Spinal System
DI: 10888857396456
·
Model: 7601-80017-G1
·
VB Spine LLC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- YUKON OCT Spinal System
- Primary DI
- 10888857396456
- Version / Model
- 7601-80017-G1
- Catalog Number
- 7601-80017-G1
- Company Name
- VB Spine LLC
- Labeler DUNS
- 119508156
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-02-15
- Public Version
- 8
- Public Version Date
- 2026-04-20
- Public Version Status
- Update
- Public Device Record Key
- ddfe331e-2d9e-4854-9707-67b82f1b23e6
Device Description
Mini Deformity Hook Pedicle Size 5.0x8.0 mm
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KWP | APPLIANCE, FIXATION, SPINAL INTERLAMINAL | Orthopedic | 888.3050 | 2 |
| NKG | Orthosis, cervical pedicle screw spinal fixation | Orthopedic | 888.3075 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65115 | Bone-screw internal spinal fixation system hook | An implantable component of a bone-screw internal spinal fixation system that has a curved (hook-shaped) design intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is typically made of metal [e.g., titanium (Ti)] and placed/hooked around the lamina or pedicle of a vertebra, without penetration (i.e., not a screw), to provide a stable connection for the system’s rod; the rod is typically stabilized in the U-shaped hook head with a small lid or screw. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10888857396456 | GS1 |
Customer Contacts
- Phone
- +1(571)919-2000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 8 | Millimeter | |
| Outer Diameter | 3.5 | Millimeter | |
| Width | 5 | Millimeter |