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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 23 of 24| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Bioplate® | 81-5728 | FDA UDI | Class II | Active |
| CranioFit | KT-T1L5H1 | FDA UDI | Class II | Active |
| Bioplate® | 81-3419 | FDA UDI | Class I | Active |
| Bioplate® | SCE4-15-01 | FDA UDI | Class II | Active |
| CranioFit | KT-T1L8H2 | FDA UDI | Class II | Active |
| Bioplate® | 81-2046 | FDA UDI | Class II | Active |
| Bioplate® | DBP4-20-SALE | FDA UDI | Class I | Active |
| Bioplate® | P4CP-08-45 | FDA UDI | Class II | Active |
| Bioplate® | AFA2-20 | FDA UDI | Class I | Active |
| Bioplate® | SCR8-04-05 | FDA UDI | Class II | Active |
| Bioplate® | SCE4-13-05 | FDA UDI | Class II | Active |
| Bioplate® | P8TP-05-14[US] | FDA UDI | Class II | Active |
| Bioplate® | P4ZR-04-21 | FDA UDI | Class II | Active |
| Bioplate® | 81-3142 | FDA UDI | Class II | Active |
| Bioplate® | 81-5726[US] | FDA UDI | Class II | Active |
| Bioplate® | P4LL-04-17 | FDA UDI | Class II | Active |
| Bioplate® | 81-7462-CP | FDA UDI | Class I | Active |
| Bioplate® | 81-2046[US] | FDA UDI | Class II | Active |
| CranioFit | KT-T7L17H2 | FDA UDI | Class II | Active |
| CranioFit | KT-T6L2H1 | FDA UDI | Class II | Active |
| CranioFit | KT-T9L8H2 | FDA UDI | Class II | Active |
| CranioFit | KT-T8L18H1 | FDA UDI | Class II | Active |
| CranioFit | KT-T1L13H2 | FDA UDI | Class II | Active |
| CranioFit | KT-T9L10H2 | FDA UDI | Class II | Active |
| CranioFit | KT-T7L12H2 | FDA UDI | Class II | Active |
| CranioFit | KT-T7L7H1 | FDA UDI | Class II | Active |
| CranioFit | KT-T1L1H1 | FDA UDI | Class II | Active |
| CranioFit | KT-T2L8H2 | FDA UDI | Class II | Active |
| CranioFit | KT-T5L13H2 | FDA UDI | Class II | Active |
| CranioFit | KT-T8L5H1 | FDA UDI | Class II | Active |
| CranioFit | KT-T3L2H1 | FDA UDI | Class II | Active |
| CranioFit | KT-T1L4H1 | FDA UDI | Class II | Active |
| CranioFit | KT-T3L13H2 | FDA UDI | Class II | Active |
| The Bioplate Rigid Fixation Bone Plating System For Craniomaxillofacial Surgery | K021684 | FDA 510(k) | Class II | Active |
| The Bioplate Resorbable Endobrow Fixation System | K051845 | FDA 510(k) | Class II | Active |
| Modification To Bioplate Bioclip Craniotomy Fixation System | K002879 | FDA 510(k) | Class II | Active |
| Modified Screw Designs For Use With The Bioplate Rigid Fixation Bone Plating System For Craniomaxillofacial Surgery | K022890 | FDA 510(k) | Class II | Active |
| Modification To The Bioplate Bioclip Craniotomy Fixation System | K011380 | FDA 510(k) | Class II | Active |
| The Bioplate Battery Powered Drill | K022986 | FDA 510(k) | Class II | Active |
| Sterile Plate & Screw Kit Configurations For Use With The Bioplate Titanium Fixation System | K022033 | FDA 510(k) | Class II | Active |
| Bioplate Resorbable Bone Screw | K012908 | FDA 510(k) | Class II | Active |
| Modification To Bioplate Rigid Bone Plating System For Craniomaxillofacial Surgery | K023665 | FDA 510(k) | Class II | Active |
| Modification To Bioplate Rigid Fixation Bone Plating System For Craniomaxillofacial Surgery | K023810 | FDA 510(k) | Class II | Active |
| Mofication To: Modified Plate Design For Bioplate Zip Craniotomy Fixation | K082175 | FDA 510(k) | Class II | Active |
| The Bioplate Bioclip Craniotomy Fixation System | K001530 | FDA 510(k) | Class II | Active |
| Bioplate Rigid Fixation Bone Plating System For Craniomaxillofacial Surgery | K030806 | FDA 510(k) | Class II | Active |
| Bioplate Rigid Bone Plating System For Craniomaxillofacial Surgery | K062819 | FDA 510(k) | Class II | Active |
| The Bioplate Mandible Fixation System | K012910 | FDA 510(k) | Class II | Active |
| The Bioplate Regid Fixation Bone Plating System For Cranomaxillofacial Surgery | K002426 | FDA 510(k) | Class II | Active |
| The Bioplate Rigid Fixation Bone Plating System For Craniomaxillofacial Surgery | K031028 | 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. |