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OptiMesh Multiplanar Expandable Interbody Fusion System
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- OptiMesh Multiplanar Expandable Interbody Fusion System FDA UDI
- Generic Name
- Endoscopic-access dilator, single-use FDA UDI
- Device Name
- Dilator Two FDA UDI
- Model / Reference
- 33-08-10 FDA UDI
- Description
- Dilator Two FDA UDI
Identifiers
- Catalog Number
- 312-0018 FDA UDI
- Primary DI / UDI-DI
- M7403120018 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Endoscopic-access dilator, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Endoscopic-access dilator, single-use
OptiMesh Multiplanar Expandable Interbody Fusion System by Spineology Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Spineology Inc.
Sources (1)
- FDA UDI 4e181483-50f6-4eaa-a7fb-1fe90a8a6ae6 35 fields · synced Jun 1, 2026