Identity
- Trade Name
- Spinal Jaxx Interbody Fusion Device FDA UDI
- Generic Name
- Metallic spinal interbody fusion cage FDA UDI
- Device Name
- Spinal Jaxx Implant, 7Hx12Wx23L mm FDA UDI
- Model / Reference
- 100001-616 FDA UDI
- Description
- Spinal Jaxx Implant, 7Hx12Wx23L mm FDA UDI
Identifiers
- Catalog Number
- 100001-616 FDA UDI
- Primary DI / UDI-DI
- 00818956020894 FDA UDI
- 510(k) Number
- K152501 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
Dimensions & Sizes
- Size
- Height — 7 Millimeter FDA UDIWidth — 12 Millimeter FDA UDILength — 23 Millimeter FDA UDI
Category: Polymeric spinal interbody fusion cageMetallic spinal interbody fusion cage
Spinal Jaxx Interbody Fusion Device by Neuropro Spinaljaxx, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Metallic spinal interbody fusion cage.
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Cleared under the same submission
K152501 also covers:
- Spinal Jaxx Interbody Fusion Device — Neuropro Spinaljaxx, Inc.
- Spinal Jaxx Interbody Fusion Device — Neuropro Spinaljaxx, Inc.
- Spinal Jaxx Interbody Fusion Device — Neuropro Spinaljaxx, Inc.
- Spinal Jaxx Interbody Fusion Device — Neuropro Spinaljaxx, Inc.
- Spinal Jaxx Interbody Fusion Device — Neuropro Spinaljaxx, Inc.
- Spinal Jaxx Interbody Fusion Device — Neuropro Spinaljaxx, Inc.
- Spinal Jaxx Interbody Fusion Device — Neuropro Spinaljaxx, Inc.
- Spinal Jaxx Interbody Fusion Device — Neuropro Spinaljaxx, Inc.
- Spinal Jaxx Interbody Fusion Device — Neuropro Spinaljaxx, Inc.
- Spinal Jaxx Interbody Fusion Device — Neuropro Spinaljaxx, Inc.
- Spinal Jaxx Interbody Fusion Device — Neuropro Spinaljaxx, Inc.
- Spinal Jaxx Interbody Fusion Device — Neuropro Spinaljaxx, 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
- Neuropro Spinaljaxx, Inc.
Sources (1)
- FDA UDI ce0c0fcf-3e95-40ed-b049-2409f59e2531 37 fields · synced May 30, 2026