FDA UDI
In Commercial Distribution
🇺🇸 United States
Carriage 5-6mm
DI: 00810017913435
·
Model: CI-CAR-1.5-5-6
·
ELEVATION SPINE, INC.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Carriage 5-6mm
- Primary DI
- 00810017913435
- Version / Model
- CI-CAR-1.5-5-6
- Catalog Number
- CI-CAR3-5-6
- Company Name
- ELEVATION SPINE, INC.
- Labeler DUNS
- 085718404
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-01-18
- Public Version
- 5
- Public Version Date
- 2025-07-17
- Public Version Status
- Update
- Public Device Record Key
- d825affa-af83-4d04-bdef-6d3baf5041d9
Device Description
Carriage 5-6mm
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 |
|---|---|---|---|---|
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | 888.3080 | 2 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Orthopedic | 888.3080 | 2 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | 888.3060 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61300 | Internal spinal fixation procedure kit, single-use | A collection of various orthopaedic manual surgical instruments (e.g., screwdriver, trial rod, adaptor, mallet, guide tube, chisel, rasp, awl, burr, tap, drill) intended to be used to perform a bone-screw internal spinal fixation and/or spinal fusion cage implantation procedure (including stereotactic procedures); implanted devices are not included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810017913435 | GS1 |
Customer Contacts
- Phone
- 844-415-0226
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K190885 | 000 |