FDA UDI
In Commercial Distribution
🇺🇸 United States
Ø3.3 Screw xxmm long implants
DI: 00810017910014
·
Model: CS-14
·
ELEVATION SPINE, INC.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Ø3.3 Screw xxmm long implants
- Primary DI
- 00810017910014
- Version / Model
- CS-14
- Catalog Number
- 1-CS-3314
- Company Name
- ELEVATION SPINE, INC.
- Labeler DUNS
- 085718404
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-12-18
- Public Version
- 2
- Public Version Date
- 2024-01-16
- Public Version Status
- Update
- Public Device Record Key
- e17b2ddf-ecbe-46e3-b45a-9f4bfbd6ed89
Device Description
Saber-C Screws, 14mm
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 |
|---|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | 888.3060 | 2 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Orthopedic | 888.3080 | 2 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | 888.3080 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43084 | Intervertebral-body internal spinal fixation system | A group of sterile implantable devices designed to apply force to a series of vertebrae to correct scoliosis (lateral curvature of the spine) or other spinal conditions. The system components are typically made of medical grade titanium and consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the centre of each plate, and a braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and is fastened or crimped at each eye-type screw. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810017910014 | GS1 |
Customer Contacts
- Phone
- 844-415-0226
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K190885 | 000 |