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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
- Spinal intraoperative positioning pin, single-use FDA UDI
- Device Name
- NiTi Guide Pin, 1.4mm x 461mm Blunt FDA UDI
- Model / Reference
- 17-02-01 FDA UDI
- Description
- NiTi Guide Pin, 1.4mm x 461mm Blunt FDA UDI
Identifiers
- Catalog Number
- 171-0001 FDA UDI
- Primary DI / UDI-DI
- M7401710001 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Spinal intraoperative positioning pin, 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
Dimensions & Sizes
- Size
- Outer Diameter — 1.4 Millimeter FDA UDILength — 461 Millimeter FDA UDI
Category: Spinal intraoperative positioning pin, 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 2fa94525-546a-4b9d-826c-429ecaa09c9a 36 fields · synced May 30, 2026