FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Reform Ti Modular
DI: 00840019975810
·
Model: 39-SB-1110
·
PRECISION SPINE, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Reform Ti Modular
- Primary DI
- 00840019975810
- Version / Model
- 39-SB-1110
- Catalog Number
- 39-SB-1110
- Company Name
- PRECISION SPINE, INC.
- Labeler DUNS
- 079398589
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-05
- Public Version
- 2
- Public Version Date
- 2025-05-01
- Public Version Status
- Update
- Public Device Record Key
- 79ee7dc1-a279-4608-8729-85a1226083f9
- Distribution End Date
- 2025-04-04
Device Description
Ø11.5 x 100mm Modular Bone Screw
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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | 888.3050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46651 | Spinal bone screw, non-bioabsorbable | A small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840019975810 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K200303 | 000 |