FDA UDI
In Commercial Distribution
🇺🇸 United States
Fuse ACP
DI: 08800033351467
·
Model: F8014-0238
·
SOLCO BIOMEDICAL CO.,LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Fuse ACP
- Primary DI
- 08800033351467
- Version / Model
- F8014-0238
- Catalog Number
- F8014-0238
- Company Name
- SOLCO BIOMEDICAL CO.,LTD.
- Labeler DUNS
- 687844241
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-24
- Public Version
- 2
- Public Version Date
- 2023-09-18
- Public Version Status
- Update
- Public Device Record Key
- 318bb82f-1502-4afe-8a80-211ae39396ce
Device Description
Fuse-ACP Anterior Cervical Plate 2Level 38mm
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 |
|---|---|---|---|---|
| 46653 | Spinal fixation plate, non-bioabsorbable | A small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures). | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08800033351467 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K182489 | 000 |