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Sign in to claim this brandBioplate, Inc.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 570 S. Melrose St., Placentia, CA, 92870
- Website
- bioplate.com
- —
- —
- [email protected]
- Phone
- 888-246-7528
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 1000518793
- DUNS Number
- 838734093
Catalogue (1156)
Page 24 of 24| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Modification Of The Bioplate Zip Craniotomy Fixation System | K020088 | FDA 510(k) | Class II | Active |
| The Bioplate Bioclip Craniotomy Fixation System | K013055 | FDA 510(k) | Class II | Active |
| Modified Plate Design For Bioplate Zip Craniotomy Fixation System | K070901 | FDA 510(k) | Class II | Active |
| Modified Sterile Plate & Screw Kit Configurations For Use With Bioplate Titanium Fixation System | K082757 | FDA 510(k) | Class II | Active |
| The Bioplate Resorbable Bone Plating System For Craniomaxillofacial Surgery, Biolactate | K994060 | FDA 510(k) | Class II | Active |
| The Bioplate Zip Craniotomy Fixation System | K013050 | FDA 510(k) | Class II | Active |
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FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Mar 31, 2010 | Z-0143-2012 | — | terminated | There is potential defect in seal of the sterile barrier containing the device. |
| Sep 12, 2006 | Z-0043-2007 | — | terminated | Lack of device sterilization: An internal investigation found products were released for distribution labeled as sterile, but the lot was not sterilized. |