Identity
- Trade Name
- CASCADIA™ Interbody System FDA UDI
- Generic Name
- Vertebral body prosthesis FDA UDI
- Device Name
- AN Interbody, Size 8.5x22x5 mm 6° FDA UDI
- Model / Reference
- 6101-2852205NL6-G2 FDA UDI
- Description
- AN Interbody, Size 8.5x22x5 mm 6° FDA UDI
Identifiers
- Catalog Number
- 6101-2852205NL6-G2 FDA UDI
- Primary DI / UDI-DI
- 10888857461772 FDA UDI
- 510(k) Number
- K160547 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Vertebral body prosthesis 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 — 5 Millimeter FDA UDILength — 22 Millimeter FDA UDIWidth — 8.5 Millimeter FDA UDIAngle — 6 degree FDA UDI
Category: Vertebral body prosthesis
CASCADIA™ Interbody System by K2m, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vertebral body prosthesis.
- FORTIFY — GLOBUS MEDICAL, INC. · Class II
- VERTE-STACK® Spinal System — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- Novel — ALPHATEC SPINE, INC. · Class II
- Regatta — SeaSpine Orthopedics Corporation · Class II
- C-THRU™ Anterior Spinal System — BIOMET SPINE LLC · Class II
- VERTE-STACK® Spinal System — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- Novel — ALPHATEC SPINE, INC. · Class II
- XPAND-R — GLOBUS MEDICAL, INC. · Class II
Cleared under the same submission
K160547 also covers:
- CASCADIA™ Interbody System — K2M, INC.
- CASCADIA™ Interbody System — K2M, INC.
- CASCADIA™ Interbody System — K2M, INC.
- CASCADIA™ Interbody System — K2M, INC.
- CASCADIA™ Interbody System — K2M, INC.
- CASCADIA™ Interbody System — K2M, INC.
- CASCADIA™ Interbody System — K2M, INC.
- CASCADIA™ Interbody System — K2M, INC.
- CASCADIA™ Interbody System — K2M, INC.
- CASCADIA™ Interbody System — K2M, INC.
- CASCADIA™ Interbody System — K2M, INC.
- CASCADIA™ Interbody System — K2M, 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
- K2m, Inc.
Sources (1)
- FDA UDI 2daac9dd-4955-48dd-84b1-eaed2769ecee 37 fields · synced May 30, 2026