Bioplate, Inc.
United StatesFDA applicant, unverified FDA FEI 1000518793
- Devices
- 1,159
- Registrations
- FDA
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
What Bioplate, Inc. makes
Bioplate, Inc. manufactures non-bioabsorbable craniofacial fixation plates and screws for cranial bone stabilization, as well as non-alterable cranioplasty plates for skull reconstruction. Their portfolio includes reusable surgical tools such as fluted drill bits, screwdrivers, instrument trays, forceps, and orthopaedic benders, designed for cranial and facial surgery procedures. Single-use and reusable components are provided to support surgical workflows in craniofacial and orthopaedic applications.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. Their products are intended for use in the United States, adhering to applicable regulatory requirements for surgical instruments and fixation hardware.
Catalogue
Search and filter all 1,159 devicesShowing 1-50 of 1,159
Company details
- FDA FEI number
- 1000518793
- DUNS number
- 838734093
- Address
- 570 S. Melrose St., Placentia, CA, 92870
- [email protected]
- Phone
- 888-246-7528
FDA recalls
FDA recall records list 2 recalls initiated by Bioplate, Inc., the earliest on 2006-09-12 and the most recent on 2010-03-31. By recorded status: 2 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, packaging and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2010
- 31 Mar 2010 Z-0143-2012 Unclassified (pre-2012) Terminated There is potential defect in seal of the sterile barrier containing the device.
2006
- 12 Sep 2006 Z-0043-2007 Unclassified (pre-2012) Terminated Lack of device sterilization: An internal investigation found products were released for distribution labeled as sterile, but the lot was not sterilized.
Frequently asked questions
How many devices does Bioplate, Inc. have in the registry?
The registry currently lists 1159 devices for Bioplate, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bioplate, Inc.'s devices?
Among its 50 most recently registered devices, Bioplate, Inc. has devices listed in FDA GUDID (50 devices).
What risk classes do Bioplate, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Bioplate, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Bioplate, Inc.?
FDA recall records list 2 recalls initiated by Bioplate, Inc., the most recent initiated on 31 Mar 2010. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Bioplate, Inc. in the registry?
The most recently registered devices listed for Bioplate, Inc. include Bioplate® 81-5737, Bioplate® 81-5739, Bioplate® 81-5738 and Bioplate® 81-5734.