FDA UDI
In Commercial Distribution
🇺🇸 United States
Neuro Plating System
DI: 08809595972899
·
Model: TCN-022
·
OSTEONIC CO.,Ltd.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Neuro Plating System
- Primary DI
- 08809595972899
- Version / Model
- TCN-022
- Company Name
- OSTEONIC CO.,Ltd.
- Labeler DUNS
- 688999370
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-12-30
- Public Version
- 3
- Public Version Date
- 2023-09-18
- Public Version Status
- Update
- Public Device Record Key
- cfa35ea7-92e5-4181-9ac8-393ba952d655
Device Description
5 x straight plates double 2 hole 15.9mm + 5 self drilling screws Ø1.95 x 4.0mm + 5 self drilling screws Ø1.5 x 4.0mm
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
- MR Conditional
- 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 |
|---|---|---|---|---|
| HBW | Fastener, Plate, Cranioplasty | Neurology | 882.5360 | 2 |
| GXR | Cover, Burr Hole | Neurology | 882.5250 | 2 |
| GWO | Plate, Cranioplasty, Preformed, Alterable | Neurology | 882.5320 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46642 | Craniofacial fixation plate, non-bioabsorbable, non-customized | A small, implantable, non-customized sheet of firm material designed to be attached with screws to craniofacial bone (including the maxilla and/or mandible) to bridge and stabilize a fracture gap or craniotomy flap, and/or cover a burr hole. It is made of non-bioabsorbable materials (e.g., surgical steel, titanium alloy) and is available in a variety of designs (e.g., Y-plate, curved plate, mesh-panel, burr hole cover). Instruments intended to facilitate implantation (e.g., driver), or plate fixation implants (i.e., bone screws), may be included with the plate. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08809595972899 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K190811 | 000 |