Identity
- Trade Name
- Leva® Anterior Expandable Spacer System FDA UDI
- Generic Name
- Metallic spinal interbody fusion cage FDA UDI
- Device Name
- Spacer, 38 mm (W) x 30 mm (D) x 15 mm (H), 8° Lordotic, 4 mm Expansion FDA UDI
- Model / Reference
- 11-0785 FDA UDI
- Description
- Spacer, 38 mm (W) x 30 mm (D) x 15 mm (H), 8° Lordotic, 4 mm Expansion FDA UDI
Identifiers
- Catalog Number
- 11-0785 FDA UDI
- Primary DI / UDI-DI
- 10840642109337 FDA UDI
- 510(k) Number
- K163246 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
No
FDA UDI
Category: Metallic spinal interbody fusion cage
Leva® Anterior Expandable Spacer 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.
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- MectaLIF 3D — Medacta International · Class II
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- 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
K163246 also covers:
- Leva® Anterior Expandable Spacer System — Spine Wave, Inc.
- Leva® Anterior Expandable Spacer System — Spine Wave, Inc.
- Leva® Anterior Expandable Spacer System — Spine Wave, Inc.
- Leva® Anterior Expandable Spacer System — Spine Wave, Inc.
- Leva® Anterior Expandable Spacer System — Spine Wave, Inc.
- Leva® Anterior Expandable Spacer System — Spine Wave, Inc.
- Leva® Anterior Expandable Spacer System — Spine Wave, Inc.
- Leva® Anterior Expandable Spacer System — Spine Wave, Inc.
- Leva® Anterior Expandable Spacer System — Spine Wave, Inc.
- Leva® Anterior Expandable Spacer System — Spine Wave, Inc.
- Leva® Anterior Expandable Spacer System — Spine Wave, Inc.
- Leva® Anterior Expandable Spacer 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 cac3547b-b1b3-4710-aa40-44dcbbfe2f45 35 fields · synced May 31, 2026