Identity
- Trade Name
- CoRoent FDA UDI
- Generic Name
- Metallic spinal interbody fusion cage FDA UDI
- Device Name
- CoRoent Ant TLIF Ti, 10x11x36mm 0° FDA UDI
- Model / Reference
- 5101360 FDA UDI
- Description
- CoRoent Ant TLIF Ti, 10x11x36mm 0° FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00887517573681 FDA UDI
- 510(k) Number
- K120918 FDA UDIK140319 FDA UDIK140659 FDA UDIK141665 FDA UDIK141896 FDA UDIK150994 FDA UDIK151472 FDA UDIK153419 FDA UDIK160916 FDA UDIK161230 FDA UDIK163707 FDA UDIK170962 FDA UDIK231735 FDA UDI
- FDA Product Code
- MQP FDA UDIMAX FDA UDIOVD FDA UDIPHM FDA UDIODP FDA UDI
- GMDN Term
- Metallic spinal interbody fusion cage FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 FDA UDI888.3080 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
Yes
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Metallic spinal interbody fusion cage
CoRoent by Nuvasive, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Metallic spinal interbody fusion cage.
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- MectaLIF 3D — Medacta International · Class II
- PILLAR TL — Orthofix US LLC · Class II
- Solar™ Interbody Fusion System — Degen Medical · Class II
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- ShurFit Lumbar Interbody — Precision Spine, Inc. · Class II
Cleared under the same submission
K120918 also covers:
K140319 also covers:
K140659 also covers:
K141665 also covers:
K141896 also covers:
K150994 also covers:
K151472 also covers:
K153419 also covers:
K160916 also covers:
K161230 also covers:
K163707 also covers:
K170962 also covers:
K231735 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Nuvasive, Inc.
Sources (1)
- FDA UDI d8b40348-f246-4313-b505-b9782018856c 35 fields · synced May 30, 2026