Identity
- Trade Name
- OmniPore Customized Surgical Implant FDA UDI
- Generic Name
- Polyethylene craniofacial tissue reconstructive material FDA UDI
- Device Name
- Cranial Implant Template (non-implantable) FDA UDI
- Model / Reference
- OP89025 FDA UDI
- Description
- Cranial Implant Template (non-implantable) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00855421005451 FDA UDI
- 510(k) Number
- K133046 FDA UDI
- FDA Product Code
- KKY FDA UDI
- GMDN Term
- Polyethylene craniofacial tissue reconstructive material FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Polyethylene craniofacial tissue reconstructive material
OmniPore Customized Surgical Implant by Matrix Surgical Holdings, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K133046 also covers:
- OmniPore Customized Surgical Implant — MATRIX SURGICAL HOLDINGS, LLC
- OmniPore Customized Surgical Implant — MATRIX SURGICAL HOLDINGS, LLC
- OmniPore Customized Surgical Implant — MATRIX SURGICAL HOLDINGS, LLC
- OmniPore Customized Surgical Implant — MATRIX SURGICAL HOLDINGS, LLC
- OmniPore Customized Surgical Implant — MATRIX SURGICAL HOLDINGS, LLC
- OmniPore Customized Surgical Implant — MATRIX SURGICAL HOLDINGS, LLC
- OmniPore Customized Surgical Implant Cutting Guide — MATRIX SURGICAL HOLDINGS, LLC
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
- Matrix Surgical Holdings, Llc
Sources (1)
- FDA UDI 06fcc6df-5b43-450f-82de-a2eb9ae8e867 34 fields · synced May 30, 2026