Identity
- Trade Name
- Leva® Anterior Interbody System FDA UDI
- Generic Name
- Metallic spinal interbody fusion cage FDA UDI
- Device Name
- Screw, 3.5 mm Hex, 5 mm x 25 mm - 3 pack FDA UDI
- Model / Reference
- 11-0025.3 FDA UDI
- Description
- Screw, 3.5 mm Hex, 5 mm x 25 mm - 3 pack FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10840642130478 FDA UDI
- 510(k) Number
- K161993 FDA UDI
- FDA Product Code
- OVD 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
No
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
Category: Metallic spinal interbody fusion cage
Leva® Anterior Interbody System by Spine Wave, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- MectaLIF 3D — Medacta International · 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
Cleared under the same submission
K161993 also covers:
- Leva® Anterior Interbody System — Spine Wave, Inc.
- Leva® Anterior Interbody System — Spine Wave, Inc.
- Leva® Anterior Interbody System — Spine Wave, Inc.
- Leva® Anterior Interbody System — Spine Wave, Inc.
- Leva® Anterior Interbody System — Spine Wave, Inc.
- Leva® Anterior Interbody System — Spine Wave, Inc.
- Leva® Anterior Interbody System — Spine Wave, Inc.
- Leva® Anterior Interbody System — Spine Wave, Inc.
- Leva® Anterior Interbody System — Spine Wave, Inc.
- Leva® Anterior Interbody System — Spine Wave, Inc.
- Leva® Anterior Interbody System — Spine Wave, Inc.
- Leva® Anterior Interbody System — Spine Wave, 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 |
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Manufacturer
- Manufacturer
- Spine Wave, Inc.
Sources (1)
- FDA UDI cb8b910f-a936-476f-95d2-4f8e1dc4eb48 34 fields · synced Jun 6, 2026