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Adaptix™ PEEK Interbody System with Nanotechnology
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Adaptix™ PEEK Interbody System with Nanotechnology FDA UDI
- Generic Name
- Metal-polymer composite spinal interbody fusion cage FDA UDI
- Device Name
- Adaptix PEEK w/ Nano 28 x 6 x 10 FDA UDI
- Model / Reference
- 74332806 FDA UDI
- Description
- Adaptix PEEK w/ Nano 28 x 6 x 10 FDA UDI
Identifiers
- Catalog Number
- 74332806 FDA UDI
- Primary DI / UDI-DI
- 00814216028358 FDA UDI
- 510(k) Number
- K241605 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Metal-polymer composite 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 28 Millimeter FDA UDIWidth — 10 Millimeter FDA UDIHeight — 6 Millimeter FDA UDI
Category: Metal-polymer composite spinal interbody fusion cage
Adaptix™ PEEK Interbody System with Nanotechnology by Nanovis Spine, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Metal-polymer composite spinal interbody fusion cage.
- Battalion Universal Spinal Spacer System — ALPHATEC SPINE, INC. · Class II
- Irix-A Lumbar Integrated Fusion System — Xtant Medical Holdings, Inc. · Class II
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- Reef TA — SeaSpine Orthopedics Corporation · Class II
- ROI-C — Ldr Spine USA · Class II
- LUCENT XP ARC — SPINAL ELEMENTS, INC. · Class II
- Shoreline ACS — SeaSpine Orthopedics Corporation · Class II
- MIDLINE II-Ti — Centinel Spine, LLC · Class II
Cleared under the same submission
K241605 also covers:
- Adaptix™ PEEK Interbody System with Nanotechnology — NANOVIS SPINE, LLC
- Adaptix™ PEEK Interbody System with Nanotechnology — NANOVIS SPINE, LLC
- Adaptix™ PEEK Interbody System with Nanotechnology — NANOVIS SPINE, LLC
- Adaptix™ PEEK Interbody System with Nanotechnology — NANOVIS SPINE, LLC
- Adaptix™ PEEK Interbody System with Nanotechnology — NANOVIS SPINE, LLC
- Adaptix™ PEEK Interbody System with Nanotechnology — NANOVIS SPINE, LLC
- Adaptix™ PEEK Interbody System with Nanotechnology — NANOVIS SPINE, LLC
- Adaptix™ PEEK Interbody System with Nanotechnology — NANOVIS SPINE, LLC
- Adaptix™ PEEK Interbody System with Nanotechnology — NANOVIS SPINE, LLC
- Adaptix™ PEEK Interbody System with Nanotechnology — NANOVIS SPINE, LLC
- Adaptix™ PEEK Interbody System with Nanotechnology — NANOVIS SPINE, LLC
- Adaptix™ PEEK Interbody System with Nanotechnology — NANOVIS SPINE, 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
- Nanovis Spine, Llc
Sources (1)
- FDA UDI 0d1afff2-fe48-4c8f-a924-d40aec728fcd 37 fields · synced Jun 1, 2026