Identity
- Trade Name
- MectaLIF 3D FDA UDI
- Generic Name
- Metallic spinal interbody fusion cage FDA UDI
- Device Name
- MectaLIF Oblique 3D 12x24x13 L20° FDA UDI
- Model / Reference
- 03.43.233 FDA UDI
- Description
- MectaLIF Oblique 3D 12x24x13 L20° FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630542737930 FDA UDI
- 510(k) Number
- K251016 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Metallic spinal interbody fusion cage FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 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
Yes
FDA UDI
Category: Metallic spinal interbody fusion cage
The MectaLIF 3D is a metallic spinal interbody fusion cage designed to promote bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease.
Similar devices
Also classified as Metallic spinal interbody fusion cage.
- KODIAK CERVICAL IMPLANT, 14x16mm, 10mmx6° — MET 1 TECHNOLOGIES, LLC · Class II
- Peridot-PT Anterior Cervical Intervertebral body fusion system — GBS Commonwealth Co., Ltd. · Class II
- CoRoent — Nuvasive, Inc. · Class II
- Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
- PILLAR TL — Orthofix US LLC · Class II
- Solar™ Interbody Fusion System — Degen Medical · Class II
- Peridot-TD Anterior Cervical Intervertebral body fusion system — GBS Commonwealth Co., Ltd. · Class II
- ShurFit Lumbar Interbody — Precision Spine, Inc. · Class II
Cleared under the same submission
K251016 also covers:
- MectaLIF 3D — Medacta International
- MectaLIF 3D — Medacta International
- MectaLIF 3D — Medacta International
- MectaLIF 3D — Medacta International
- MectaLIF 3D — Medacta International
- MectaLIF 3D — Medacta International
- MectaLIF 3D — Medacta International
- MectaLIF 3D — Medacta International
- MectaLIF 3D — Medacta International
- MectaLIF 3D — Medacta International
- MectaLIF 3D — Medacta International
- MectaLIF 3D — Medacta International
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 |
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Manufacturer
- Manufacturer
- Medacta International
Sources (1)
- FDA UDI bd2bf2d9-4da5-44da-964f-56aaaa037b9f 34 fields · synced Jul 11, 2026