Data / Medical devices / United States / Bioplate, Inc.
Bioplate, Inc.: FDA-registered device maker in Placentia, CA, United States, 11 510(k) clearances
Bioplate, Inc. is registered with the FDA (registration 2029447) in Placentia, CA, United States. It lists 10 device types. The FDA files 11 510(k) clearances under its listings, the newest dated October 28, 2022. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2029447
- FEI number
- 1000518793
- Address
- 570 S. Melrose St., Placentia, CA, United States, 92870
- Owner or operator
- Bioplate, Inc. (9016123)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer
- First device listed
- February 28, 2008
- Registered through
- 2026
- Brand names listed
- Bioplate Forceps, Plate Holding, Bioplate Plate Bender, Bioplate Plate Cutter / Mesh Cutting Scissors, Bioplate Rigid Fixation Bone, Bioplate Titanium Fixation System, CranioFit, Modified Sterile Plate & Screw kit configurations for use with Bioplate Titanium Fixation System, Neurosurgery Fixation System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cover, Burr Hole | GXR | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Cutter, Surgical | FZT | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Filler, Bone Void, Calcium Compound | MQV | 2 | Contract manufacturer | accessdata.fda.gov |
| Forceps | HTD | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Instrument, Bending Or Contouring | HXP | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Plate, Bone | JEY | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Plate, Cranioplasty, Preformed, Non-Alterable | GXN | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Plate, Fixation, Bone | HRS | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Screwdriver, Surgical | LRZ | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 28, 2022 | K214109 | PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) | GXN | Substantially Equivalent | Kontour(XiAn) Medical Technology Co., Ltd. | accessdata.fda.gov |
| October 1, 2008 | K082757 | MODIFIED STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH BIOPLATE TITANIUM FIXATION SYSTEM | JEY | Substantially Equivalent | Bioplate, Inc. | accessdata.fda.gov |
| November 22, 2002 | K023665 | MODIFICATION TO BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | JEY | Substantially Equivalent | Bioplate, Inc. | accessdata.fda.gov |
| September 6, 2002 | K022890 | MODIFIED SCREW DESIGNS FOR USE WITH THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | JEY | Substantially Equivalent | Bioplate, Inc. | accessdata.fda.gov |
| June 26, 2002 | K021684 | THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | JEY | Substantially Equivalent | Bioplate, Inc. | accessdata.fda.gov |
| January 26, 2001 | K002426 | THE BIOPLATE REGID FIXATION BONE PLATING SYSTEM FOR CRANOMAXILLOFACIAL SURGERY | JEY | Substantially Equivalent | Bioplate, Inc. | accessdata.fda.gov |
| November 23, 1999 | K992330 | THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | JEY | Substantially Equivalent | Biomedics | accessdata.fda.gov |
| June 9, 1998 | K980983 | THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | JEY | Substantially Equivalent | Biomedics | accessdata.fda.gov |
| September 25, 1997 | K972463 | THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | JEY | Substantially Equivalent | Biomedics | accessdata.fda.gov |
| September 29, 1995 | K953273 | BIOPLATE RIGID FIXATION BONE PLATING SYSTEM | JEY | Substantially Equivalent | Biomedics | accessdata.fda.gov |
| January 6, 1995 | K943071 | THE TITANIUM FIXATION SYSTEM | JEY | Substantially Equivalent | Biomedics | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 31, 2010 | 55537 | Not yet classified | Terminated | 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 | There is potential defect in seal of the sterile barrier containing the device. | accessdata.fda.gov |
| September 12, 2006 | 36362 | Not yet classified | Terminated | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Screwdriver, Surgical
- All makers of Instrument, Bending Or Contouring
- All makers of Plate, Bone
- All makers of Plate, Fixation, Bone
- All makers of Forceps
- All makers of Filler, Bone Void, Calcium Compound
Updated October 28, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.