Identity
- Trade Name
- Spine Innovation Interbody System FDA UDI
- Generic Name
- Polymeric spinal fusion cage, sterile FDA UDI
- Device Name
- Trial, 5° x 12mm W x 16mm H FDA UDI
- Model / Reference
- 90-SDA-120016 FDA UDI
- Description
- Trial, 5° x 12mm W x 16mm H FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817722020717 FDA UDI
- 510(k) Number
- K153356 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Polymeric spinal fusion cage, sterile 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
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Polymeric spinal fusion cage, sterile
Spine Innovation Interbody System by Spine Innovation, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Polymeric spinal fusion cage, sterile.
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Cleared under the same submission
K153356 also covers:
- Spine Innovation Interbody System — SPINE INNOVATION, LLC
- Spine Innovation Interbody System — SPINE INNOVATION, LLC
- Spine Innovation Interbody System — SPINE INNOVATION, LLC
- Spine Innovation Interbody System — SPINE INNOVATION, LLC
- Spine Innovation Interbody System — SPINE INNOVATION, LLC
- Spine Innovation Interbody System — SPINE INNOVATION, LLC
- Spine Innovation Interbody System — SPINE INNOVATION, LLC
- Spine Innovation Interbody System — SPINE INNOVATION, LLC
- Spine Innovation Interbody System — SPINE INNOVATION, LLC
- Spine Innovation Interbody System — SPINE INNOVATION, LLC
- Spine Innovation Interbody System — SPINE INNOVATION, LLC
- Spine Innovation Interbody System — SPINE INNOVATION, LLC
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 Innovation, Llc
Sources (1)
- FDA UDI a2600159-3345-46a0-a092-3999b604a4b2 34 fields · synced Jun 1, 2026