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CirFIX® Cranial bone fixation system: Burr Hole Cover
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- CirFIX® Cranial bone fixation system: Burr Hole Cover FDA UDI
- Generic Name
- Craniofacial fixation plate, non-bioabsorbable, non-customized FDA UDI
- Device Name
- CUSMED CirFIX® Burr Hole Cover, Radiolucent Revisable Type for Shunt & ICP+Screwdriver, PEEK, 14mm/11mm, Sterile FDA UDI
- Model / Reference
- 9906.0014.11S FDA UDI
- Description
- CUSMED CirFIX® Burr Hole Cover, Radiolucent Revisable Type for Shunt & ICP+Screwdriver, PEEK, 14mm/11mm, Sterile FDA UDI
Identifiers
- Catalog Number
- 9906.0014.11S FDA UDI
- Primary DI / UDI-DI
- 04717002404335 FDA UDI
- 510(k) Number
- K192310 FDA UDI
- FDA Product Code
- GXR FDA UDI
- GMDN Term
- Craniofacial fixation plate, non-bioabsorbable, non-customized FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Craniofacial fixation plate, non-bioabsorbable, non-customized
CirFIX® Cranial bone fixation system: Burr Hole Cover by Ossaware Biotech Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Craniofacial fixation plate, non-bioabsorbable, non-customized.
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- TraumaOne SYSTEM — BIOMET MICROFIXATION, INC · Class II
- Leforte System Bone Plate — Jeil Medical Corporation · Class II
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- Leforte Neuro System Bone Plate — Jeil Medical Corporation · Class II
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ossaware Biotech Co., Ltd.
Sources (1)
- FDA UDI 1525ab7c-931d-41a8-bc2a-0a88af140b8a 36 fields · synced Jun 1, 2026