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Sign in to claim this brandBioplate, Inc.
US
Last updated September 17, 2026
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.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Bioplate, Inc. manufacture?
Bioplate, Inc. specializes in craniofacial and cranial surgical devices. Their portfolio includes non-bioabsorbable fixation plates and screws for stabilizing cranial bones, non-alterable cranioplasty plates for skull reconstruction, and reusable surgical tools like fluted drill bits, screwdrivers, instrument trays, forceps, and orthopaedic benders. These tools are designed to support surgical workflows in craniofacial and orthopaedic procedures.
Where is Bioplate, Inc. based, and what regulatory database lists its devices?
Bioplate, Inc. is based in the United States. Their devices are listed in the FDA’s Unique Device Identifier (UDI) database, which serves as a centralized registry for tracking medical devices authorized for use in the U.S. This database helps ensure traceability and compliance with regulatory requirements.
How are Bioplate, Inc.’s devices classified under FDA regulations?
Bioplate, Inc.’s devices fall under two FDA classification categories: Class I and Class II. Class I devices generally pose the lowest risk and may require minimal regulatory oversight, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body area it interacts with.
What is the purpose of the reusable surgical tools offered by Bioplate, Inc.?
The reusable surgical tools from Bioplate, Inc., such as fluted drill bits, screwdrivers, instrument trays, forceps, and orthopaedic benders, are designed to assist surgeons in craniofacial and cranial procedures. These tools are engineered for durability and precision, ensuring they can be sterilized and reused across multiple surgeries while maintaining performance standards for safe and effective surgical interventions.
Why are some of Bioplate, Inc.’s devices classified as Class II?
Bioplate, Inc.’s devices are classified as Class II because they involve moderate risk to patients. For example, craniofacial fixation plates and screws, while non-bioabsorbable, require precise placement to stabilize cranial bones, reducing the risk of complications like infection or improper healing. The FDA imposes special controls for these devices—such as performance standards, labeling requirements, or post-market surveillance—to ensure their safety and effectiveness before they reach the market.
AI-generated from registry data and not verified by a human reviewer.
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 19 of 24| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Bioplate® | 81-2034-CP | FDA UDI | Class I | Active |
| Bioplate® | P2RP-05-33 | FDA UDI | Class II | Active |
| Bioplate® | 81-3031-CP | FDA UDI | Class II | Active |
| Bioplate® | 81-3147 | FDA UDI | Class II | Active |
| Bioplate® | 81-3036 | FDA UDI | Class II | Active |
| Bioplate® | SCE4-06-01 | FDA UDI | Class II | Active |
| Bioplate® | P2TW-05-19 | FDA UDI | Class II | Active |
| Bioplate® | 81-2093 | FDA UDI | Class II | Active |
| Bioplate® | DBP2-14-SALE | FDA UDI | Class I | Active |
| Bioplate® | 81-2017 | FDA UDI | Class II | Active |
| CranioFit | KT-T7L8H2 | FDA UDI | Class II | Active |
| Bioplate® | 81-2078[US] | FDA UDI | Class II | Active |
| Bioplate® | SCR8-12-05 | FDA UDI | Class II | Active |
| Bioplate® | 81-2069-CP | FDA UDI | Class II | Active |
| Bioplate® | SCR2-08-01 | FDA UDI | Class II | Active |
| Bioplate® | 81-3028 | FDA UDI | Class II | Active |
| Bioplate® | 81-2070 | FDA UDI | Class II | Active |
| CranioFit | KT-T1L11H2 | FDA UDI | Class II | Active |
| CranioFit | KT-T3L8H2 | FDA UDI | Class II | Active |
| Bioplate® | 81-3413 | FDA UDI | Class I | Active |
| Bioplate® | 81-3529 | FDA UDI | Class II | Active |
| Bioplate® | SCR2-04-05[US] | FDA UDI | Class II | Active |
| Bioplate® | 81-5791-CP | FDA UDI | Class II | Active |
| CranioFit | KT-T8L4H1 | FDA UDI | Class II | Active |
| Bioplate® | 81-3109 | FDA UDI | Class I | Active |
| Bioplate® | SCE8-04-05 | FDA UDI | Class II | Active |
| CranioFit | KT-T5L8H2 | FDA UDI | Class II | Active |
| Bioplate® | DBP4-06 | FDA UDI | Class I | Active |
| Bioplate® | SCR2-12-05 | FDA UDI | Class II | Active |
| CranioFit | KT-T3L3H1 | FDA UDI | Class II | Active |
| Bioplate® | 81-3029 | FDA UDI | Class II | Active |
| CranioFit | KT-T1L9H2 | FDA UDI | Class II | Active |
| Bioplate® | 81-5740[US] | FDA UDI | Class II | Active |
| Bioplate® | 81-3043[US] | FDA UDI | Class II | Active |
| Bioplate® | 81-5733-CP | FDA UDI | Class II | Active |
| Bioplate® | 81-3107 | FDA UDI | Class I | Active |
| Bioplate® | ASB8-25-SALE | FDA UDI | Class I | Active |
| Bioplate® | SCR4-08-05 | FDA UDI | Class II | Active |
| Bioplate® | SCR4-06-05[US] | FDA UDI | Class II | Active |
| Bioplate® | P2XP-04-14 | FDA UDI | Class II | Active |
| Bioplate® | P2CK-06-32 | FDA UDI | Class II | Active |
| Bioplate® | 81-7314 | FDA UDI | Class II | Active |
| Bioplate® | SCE4-05-01 | FDA UDI | Class II | Active |
| Bioplate® | SCR2-10-05 | FDA UDI | Class II | Active |
| CranioFit | KT-T3L11H2 | FDA UDI | Class II | Active |
| Bioplate® | 81-3085 | FDA UDI | Class I | Active |
| Bioplate® | 81-3517 | FDA UDI | Class II | Unknown |
| Bioplate® | 81-3410 | FDA UDI | Class I | Active |
| Bioplate® | 81-3571 | FDA UDI | Class I | Active |
| Bioplate® | 81-3181-CP | FDA UDI | 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.
Bioplate, Inc. has two FDA recall records, both initiated in 2006 and 2010, respectively. Both recalls were terminated. The first involved a potential defect in the seal of the sterile barrier containing the device, while the second was due to a lack of device sterilization, where products were distributed labeled as sterile despite not undergoing sterilization.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| 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. |