FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Facet screw
DI: 07290019421238
·
Model: 1
·
ZYGOFIX LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Facet screw
- Primary DI
- 07290019421238
- Version / Model
- 1
- Catalog Number
- ZF-40FS-20TU
- Company Name
- ZYGOFIX LTD
- Labeler DUNS
- 532143561
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-05
- Public Version
- 3
- Public Version Date
- 2024-10-21
- Public Version Status
- Update
- Public Device Record Key
- aef19879-3623-4e5d-9d47-939ad88c0d34
- Distribution End Date
- 2024-09-05
Device Description
The subjected screw is part of the zLOCK Lumbar Facet Fixation System. The zLOCK Lumbar Facet Fixation System is a modular facet screw system for posterior lumbar spinal stabilization. The zLOCK Lumbar Facet Fixation System consists of two main components: 1) a Facet Screw with a washer and 2) a Modular spacer. The system including a dedicated tool set.
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
- Yes
- 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 |
|---|---|---|---|---|
| MRW | System, Facet Screw Spinal Device | Unknown | U |
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 | 07290019421238 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K240085 | 000 |
Storage Conditions
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 700 – 1013 millibar
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 80 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius