CranioFit CF26080002
GUDID M384CF260800020
CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)
Bioplate, Inc.
Cranioplasty plate, non-alterable| Primary Device ID | M384CF260800020 |
| NIH Device Record Key | 5d28d1a0-e50e-43bc-94c6-581ae68ca8c1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CranioFit |
| Version Model Number | KT-T8L2H1 |
| Catalog Number | CF26080002 |
| Company DUNS | 838734093 |
| Company Name | Bioplate, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M384CF260800020 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K214109
FDA Product Code
| GXN | Plate, Cranioplasty, Preformed, Non-Alterable |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M384CF260800020]
Moist Heat or Steam Sterilization
[M384CF260800020]
Moist Heat or Steam Sterilization
[M384CF260800020]
Moist Heat or Steam Sterilization
[M384CF260800020]
Moist Heat or Steam Sterilization
[M384CF260800020]
Moist Heat or Steam Sterilization
[M384CF260800020]
Moist Heat or Steam Sterilization
[M384CF260800020]
Moist Heat or Steam Sterilization
[M384CF260800020]
Moist Heat or Steam Sterilization
[M384CF260800020]
Moist Heat or Steam Sterilization
[M384CF260800020]
Moist Heat or Steam Sterilization
[M384CF260800020]
Moist Heat or Steam Sterilization
[M384CF260800020]
Moist Heat or Steam Sterilization
[M384CF260800020]
Moist Heat or Steam Sterilization
[M384CF260800020]
Moist Heat or Steam Sterilization
[M384CF260800020]
Moist Heat or Steam Sterilization
[M384CF260800020]
Moist Heat or Steam Sterilization
[M384CF260800020]
Moist Heat or Steam Sterilization
[M384CF260800020]
Moist Heat or Steam Sterilization
[M384CF260800020]
Moist Heat or Steam Sterilization
[M384CF260800020]
Moist Heat or Steam Sterilization
[M384CF260800020]
Moist Heat or Steam Sterilization
[M384CF260800020]
Moist Heat or Steam Sterilization
[M384CF260800020]
Moist Heat or Steam Sterilization
[M384CF260800020]
Moist Heat or Steam Sterilization
[M384CF260800020]
Moist Heat or Steam Sterilization
[M384CF260800020]
Moist Heat or Steam Sterilization
[M384CF260800020]
Moist Heat or Steam Sterilization
[M384CF260800020]
Moist Heat or Steam Sterilization
[M384CF260800020]
Moist Heat or Steam Sterilization
[M384CF260800020]
Moist Heat or Steam Sterilization
[M384CF260800020]
Moist Heat or Steam Sterilization
[M384CF260800020]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-10-18 |
| Device Publish Date | 2024-10-10 |
On-Brand Devices [CranioFit]
| M384CF260900180 | CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
| M384CF260900170 | CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
| M384CF260900160 | CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
| M384CF260900150 | CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
| M384CF260900140 | CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
| M384CF260900130 | CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
| M384CF260900120 | CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
| M384CF260900110 | CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
| M384CF260900100 | CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
| M384CF260900090 | CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
| M384CF260900080 | CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
| M384CF260900070 | CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
| M384CF260900060 | CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
| M384CF260900050 | CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
| M384CF260900040 | CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
| M384CF260900020 | CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
| M384CF260900010 | CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
| M384CF260800180 | CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
| M384CF260800170 | CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
| M384CF260800160 | CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
| M384CF260800150 | CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
| M384CF260800140 | CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
| M384CF260800130 | CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
| M384CF260800120 | CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
| M384CF260800110 | CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
| M384CF260800100 | CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
| M384CF260800090 | CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
| M384CF260800080 | CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
| M384CF260800070 | CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
| M384CF260800060 | CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
| M384CF260800050 | CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
| M384CF260800040 | CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
| M384CF260800030 | CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
| M384CF260800020 | CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
| M384CF260800010 | CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
| M384CF260700180 | CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
| M384CF260700170 | CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
| M384CF260700160 | CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
| M384CF260700150 | CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
| M384CF260700140 | CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
| M384CF260700130 | CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
| M384CF260700120 | CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
| M384CF260700110 | CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
| M384CF260700100 | CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
| M384CF260700090 | CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
| M384CF260700080 | CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
| M384CF260700070 | CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
| M384CF260700060 | CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
| M384CF260700050 | CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
| M384CF260700040 | CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
Trademark Results [CranioFit]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CRANIOFIT 90836385 not registered Live/Pending |
Bioplate, Inc. 2021-07-19 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.