FDA Registration
Active
🇺🇸 United States
BIOPLATE, INC.
Reg #: 2029447
·
FEI: 1000518793
·
Expires 2026
Products
10
Proprietary Names
16
Establishment Types
4
Classifications
10
Registration Details
- Registration Name
- BIOPLATE, INC.
- Registration Number
- 2029447
- FEI Number
- 1000518793
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 570 S. Melrose St.
- City
- Placentia
- State
- CA
- ZIP
- 92870
- Country
- US
Regulatory Submissions
- 510(k) Number
- K023665
Owner / Operator
- Firm Name
- Bioplate, Inc.
- Operator Number
- 9016123
- Address
- 570 S. Melrose St.
- City
- Placentia
- State
- CA
- Postal Code
- 92870
- Country
- US
- Correspondent
- Yoon Choi
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Plate, Bone | JEY | Class 2 | Dental | No | 2008-02-28 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2024-04-17 |
| Plate, Cranioplasty, Preformed, Non-Alterable | GXN | Class 2 | Neurology | No | 2024-07-26 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2015-12-02 |
| Screwdriver, Surgical | LRZ | Class 1 | General, Plastic Surgery | No | 2015-12-01 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 2024-04-17 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2015-12-01 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2024-04-17 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2018-12-12 |
| Cover, Burr Hole | GXR | Class 2 | Neurology | No | 2015-12-01 |
Proprietary Names
Rigid Fixation Bone Plating System
Bioplate Plate Cutter / Mesh Cutting Scissors
The Titanium Fixation System
Titanium Fixation System
CranioFit
Bioplate Rigid Fixation Bone
Bioplate Titanium Fixation System
Bioplate Plate Bender
The Bioplate Rigid Bone Plating System for Craniomaxillofacial Surgery
Modified Sterile Plate & Screw kit configurations for use with Bioplate Titanium Fixation System
Screws for Rigid Fixation Bone
Plating System
Bioplate Forceps, Plate Holding
The Bioplate Rigid Fixation bone plating system for Craniomaxillofacial surgery
The Bioplate Rigid Fixation System
Neurosurgery Fixation System
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device for Another Party (Contract Manufacturer)