FDA UDI
In Commercial Distribution
🇺🇸 United States
King Cobra
DI: B014KCP4014
·
Model: KCP4014
·
EMINENT SPINE LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- King Cobra
- Primary DI
- B014KCP4014
- Version / Model
- KCP4014
- Company Name
- EMINENT SPINE LLC
- Labeler DUNS
- 022576742
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-09
- Public Version
- 3
- Public Version Date
- 2019-04-29
- Public Version Status
- Update
- Public Device Record Key
- e71696bc-b27f-4c34-ad27-cbd9948707e8
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
- 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 |
|---|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | 888.3060 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42848 | External spinal fixation system | An assembly of devices designed to stabilize adjacent segments (i.e., vertebrae) of the spine. It typically consists of an external plastic and/or metallic fixator and other external and/or implantable components, such as plates, rods, pins, and bone screws; it may also include some instruments appropriate for attaching the implants (e.g., screw drivers, wrenches, drills). The system is intended for temporary immobilization of segments of the spine in patients with fractures of the thoracic and/or lumbar spine and also for some patients suffering of segmental instability or chronic back pain. This is a reusable device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B014KCP4014 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K103068 | 000 |