Identity
- Trade Name
- OptiMesh 1500 S FDA UDI
- Generic Name
- Vertebral body bone graft pouch FDA UDI
- Device Name
- Surgical Mesh FDA UDI
- Model / Reference
- 10-10-04-3 FDA UDI
- Description
- Surgical Mesh FDA UDI
Identifiers
- Catalog Number
- 300-2702 FDA UDI
- Primary DI / UDI-DI
- M7403002702 FDA UDI
- 510(k) Number
- K014200 FDA UDI
- FDA Product Code
- EZX FDA UDI
- GMDN Term
- Vertebral body bone graft pouch FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3300 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
Radiation Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 27 Millimeter FDA UDI
Category: Vertebral body bone graft pouch
OptiMesh 1500 S by Spineology Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K014200 also covers:
- OptiMesh 1500 E — SPINEOLOGY INC.
- OptiMesh 1500 E — SPINEOLOGY INC.
- OptiMesh 1500 E — SPINEOLOGY INC.
- OptiMesh 1500 E — SPINEOLOGY INC.
- OptiMesh 1500 E — SPINEOLOGY INC.
- OptiMesh 1500 S — SPINEOLOGY INC.
- OptiMesh 1500 S — SPINEOLOGY INC.
- OptiMesh DS — SPINEOLOGY INC.
- OptiMesh DS — SPINEOLOGY INC.
- OptiMesh DS — SPINEOLOGY INC.
- OptiMesh DS — SPINEOLOGY INC.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Spineology Inc.
Sources (1)
- FDA UDI aea39034-dc36-47c6-bbef-7cf9e1cfa489 37 fields · synced Jun 8, 2026