FDA UDI
In Commercial Distribution
🇺🇸 United States
GSO PCT Spinal System
DI: M9935062800
·
Model: 506280
·
UNIFIED SPINE, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- GSO PCT Spinal System
- Primary DI
- M9935062800
- Version / Model
- 506280
- Company Name
- UNIFIED SPINE, LLC
- Labeler DUNS
- 118413370
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-12
- Public Version
- 5
- Public Version Date
- 2024-06-17
- Public Version Status
- Update
- Public Device Record Key
- c6fd21c2-1746-4aec-aaa5-a7bce72f3e27
Device Description
PCT Hook for 3.5mm Rod System
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | 888.3050 | 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 | M9935062800 | HIBCC |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 6.0mm Hook for 3.5mm Rod System |