Identity
- Trade Name
- Mesh FDA UDI
- Generic Name
- Vertebral body prosthesis FDA UDI
- Device Name
- Mesh, 10x9mm FDA UDI
- Model / Reference
- 1007636 FDA UDI
- Description
- Mesh, 10x9mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00887517054944 FDA UDI
- 510(k) Number
- K023319 FDA UDI
- FDA Product Code
- MQP FDA UDI
- GMDN Term
- Vertebral body prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Vertebral body prosthesis
Mesh by Nuvasive, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vertebral body prosthesis.
- CASCADIA™ Interbody System — K2M, INC. · Class II
- CHESAPEAKE® Stabilization System — K2M, INC. · Class II
- CASCADIA™ Interbody System — K2M, INC. · Class II
- FORTIFY — GLOBUS MEDICAL, INC. · Class II
- VERTE-STACK® Spinal System — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- CASCADIA™ Interbody System — K2M, INC. · Class II
- CAPRI™ Corpectomy Cage System — K2M, INC. · Class II
- Cascadia™ Interbody System — K2M, INC. · Class II
Cleared under the same submission
K023319 also covers:
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
- Nuvasive, Inc.
Sources (1)
- FDA UDI 157696d5-17ca-4b38-83e3-2919d58c5eac 35 fields · synced Jun 8, 2026