Bioplate Inc
Placentia, CA, US
BIOPLATE, INC. appears in FDA device records in Placentia, CA. FDA records list 23 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 23 510(k) clearances for Bioplate Inc between 2000 and 2008. The busiest year on record is 2001, with 7. The most recent is 2008, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 2 |
| 2001 | 7 |
| 2002 | 7 |
| 2003 | 2 |
| 2005 | 1 |
| 2006 | 1 |
| 2007 | 1 |
| 2008 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K082757 | MODIFIED STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH BIOPLATE TITANIUM FIXATION SYSTEM | JEY | Substantially Equivalent | |
| K082175 | MOFICATION TO: MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION | GXN | Substantially Equivalent | |
| K070901 | MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM | GXN | Substantially Equivalent | |
| K062819 | BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | GXN | Substantially Equivalent | |
| K051845 | THE BIOPLATE RESORBABLE ENDOBROW FIXATION SYSTEM | JEY | Substantially Equivalent | |
| K031028 | THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | JEY | Substantially Equivalent | |
| K030806 | BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | JEY | Substantially Equivalent | |
| K023810 | MODIFICATION TO BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | JEY | Substantially Equivalent | |
| K023665 | MODIFICATION TO BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | JEY | Substantially Equivalent | |
| K022986 | THE BIOPLATE BATTERY POWERED DRILL | HBC | Substantially Equivalent | |
| K022890 | MODIFIED SCREW DESIGNS FOR USE WITH THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | JEY | Substantially Equivalent | |
| K022033 | STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH THE BIOPLATE TITANIUM FIXATION SYSTEM | JEY | Substantially Equivalent | |
| K021684 | THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | JEY | Substantially Equivalent | |
| K020088 | MODIFICATION OF THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM | GXN | Substantially Equivalent | |
| K013050 | THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM | GXN | Substantially Equivalent | |
| K013055 | THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM | JEY | Substantially Equivalent | |
| K012908 | BIOPLATE RESORBABLE BONE SCREW | DZL | Substantially Equivalent | |
| K012910 | THE BIOPLATE MANDIBLE FIXATION SYSTEM | JEY | Substantially Equivalent | |
| K011380 | MODIFICATION TO THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM | JEY | Substantially Equivalent | |
| K002426 | THE BIOPLATE REGID FIXATION BONE PLATING SYSTEM FOR CRANOMAXILLOFACIAL SURGERY | JEY | Substantially Equivalent | |
| K994060 | THE BIOPLATE RESORBABLE BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY, BIOLACTATE | JEY | Substantially Equivalent | |
| K002879 | MODIFICATION TO BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM | JEY | Substantially Equivalent | |
| K001530 | THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM | JEY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2029447 | 1000518793 | BIOPLATE, INC. | 570 S. Melrose St., Placentia, CA 92870 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GXRCover, Burr Hole
- FZTCutter, Surgical
- MQVFiller, Bone Void, Calcium Compound
- HTDForceps
- HXPInstrument, Bending Or Contouring
- HBCMotor, Drill, Electric
- JEYPlate, Bone
- GXNPlate, Cranioplasty, Preformed, Non-Alterable
- HRSPlate, Fixation, Bone
- DZLScrew, Fixation, Intraosseous
- LRZScrewdriver, Surgical
- FSMTray, Surgical, Instrument
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0143-2012 | Bioplate Titanium Fixation System, Sterile Kit. The sterile plate and screw kit configurations for use with the Bioplate Titanium Fixation System are intended for use on non-load bearing fixation, including cranial bone fixation and brow fixation and the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implant. | There is potential defect in seal of the sterile barrier containing the device. | Terminated | ||
| Z-0043-2007 | Bioplate Resorbable Bone Fixation Tack, Catalog Number: 89-0120, Item Number: SG#-45 | Lack of device sterilization: An internal investigation found products were released for distribution labeled as sterile, but the lot was not sterilized. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain