Identity
- Trade Name
- EVOS Lumbar Interbody System FDA UDI
- Generic Name
- Polymeric spinal fusion cage, sterile FDA UDI
- Device Name
- HA PEEK EVOS Rotate, , 12mmx11mmx 22mm , BICONVEX 8 degree FDA UDI
- Model / Reference
- 4482-012 FDA UDI
- Description
- HA PEEK EVOS Rotate, , 12mmx11mmx 22mm , BICONVEX 8 degree FDA UDI
Identifiers
- Catalog Number
- 4482-012 FDA UDI
- Primary DI / UDI-DI
- 00841193112152 FDA UDI
- 510(k) Number
- K150321 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
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 22 Millimeter FDA UDI
Category: Polymeric spinal fusion cage, sterile
A comprehensive medical device for spinal fusion, providing stable fixation and sufficient space for bone fusion to occur.
Similar devices
Also classified as Polymeric spinal fusion cage, sterile.
- TALOS® IBF — MEDITECH SPINE, LLC · Class II
- ROCCIA — Silony Medical GmbH · Class II
- TiNano — AURORA SPINE, INC. · Class II
- Aurora Spine — AURORA SPINE, INC. · Class II
- TALOS®-C — MEDITECH SPINE, LLC · Class II
- Avenue T — Ldr Spine USA · Class II
- VertebraLINK MI — LINKSPINE, INC. · Class I
- TALOS® IBF — MEDITECH SPINE, LLC · Class II
Cleared under the same submission
K150321 also covers:
- EVOS Lumbar Interbody System — CUTTING EDGE SPINE
- EVOS Lumbar Interbody System — CUTTING EDGE SPINE
- EVOS Lumbar Interbody System — CUTTING EDGE SPINE
- EVOS Lumbar Interbody System — CUTTING EDGE SPINE
- EVOS Lumbar Interbody System — CUTTING EDGE SPINE
- EVOS Lumbar Interbody System — CUTTING EDGE SPINE
- EVOS Lumbar Interbody System — CUTTING EDGE SPINE
- EVOS Lumbar Interbody System — CUTTING EDGE SPINE
- EVOS Lumbar Interbody System — CUTTING EDGE SPINE
- EVOS Lumbar Interbody System — CUTTING EDGE SPINE
- EVOS Lumbar Interbody System — CUTTING EDGE SPINE
- EVOS Lumbar Interbody System — CUTTING EDGE SPINE
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cutting Edge Spine
Sources (1)
- FDA UDI 309e3b67-81ea-4ee0-b18c-543387894bd4 38 fields · synced Jun 26, 2026