FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Certex Spinal Fixation System
DI: M697X06715541
·
Model: X067-1554
·
Xtant Medical Holdings, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Certex Spinal Fixation System
- Primary DI
- M697X06715541
- Version / Model
- X067-1554
- Company Name
- Xtant Medical Holdings, Inc.
- Labeler DUNS
- 081224143
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-21
- Public Version
- 6
- Public Version Date
- 2025-04-24
- Public Version Status
- Update
- Public Device Record Key
- c3a48856-f9f7-49f7-90de-084a6506df54
- Distribution End Date
- 2024-12-16
Device Description
CERTEX 4.0 X 24mm THREADED X 10mm SMOOTH X 34mm OVERALL SMOOTH SHANK SCREW ASSEMBLY
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
- 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 |
| NKG | Posterior cervical screw system | Orthopedic | 888.3075 | 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 | M697X06715541 | HIBCC |
Customer Contacts
- Phone
- +1(888)886-9354
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 24 | Millimeter | |
| Outer Diameter | 4 | Millimeter | |
| Length | 10 | Millimeter |