Identity
- Trade Name
- ATLAS® Cable System FDA UDI
- Generic Name
- Internal spinal fixation system cable FDA UDI
- Device Name
- CABLE 826-013 SNGL CBL WINTGL CRMP SS FDA UDI
- Model / Reference
- 826-013 FDA UDI
- Description
- CABLE 826-013 SNGL CBL WINTGL CRMP SS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00673978047898 FDA UDI
- 510(k) Number
- K892651 FDA UDI
- FDA Product Code
- LRN FDA UDI
- GMDN Term
- Internal spinal fixation system cable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 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
No
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
Category: Internal spinal fixation system cable
ATLAS® Cable System by Medtronic Sofamor Danek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Internal spinal fixation system cable.
- Songer® Spinal Cable System — Pioneer Surgical Technology, Inc. · Class II
- Songer® Spinal Cable System — Pioneer Surgical Technology, Inc. · Class II
- VersaTie — Nuvasive, Inc. · Class II
- Songer® Spinal Cable System — Pioneer Surgical Technology, Inc. · Class II
- NILE™ Alternative Fixation System — K2M, INC. · Class II
- Songer® Spinal Cable System — Pioneer Surgical Technology, Inc. · Class II
- Songer® Spinal Cable System — Pioneer Surgical Technology, Inc. · Class II
- Songer® Spinal Cable System — Pioneer Surgical Technology, Inc. · Class II
Cleared under the same submission
K892651 also covers:
- ATLAS® Cable System — MEDTRONIC SOFAMOR DANEK, INC.
- ATLAS® Cable System — MEDTRONIC SOFAMOR DANEK, INC.
- ATLAS® Cable System — MEDTRONIC SOFAMOR DANEK, INC.
- ATLAS® Cable System — MEDTRONIC SOFAMOR DANEK, INC.
- ATLAS® Cable System — MEDTRONIC SOFAMOR DANEK, INC.
- ATLAS® Cable System — MEDTRONIC SOFAMOR DANEK, INC.
- ATLAS® Cable System — MEDTRONIC SOFAMOR DANEK, INC.
- ATLAS® Cable System — MEDTRONIC SOFAMOR DANEK, INC.
- ATLAS® Cable System — MEDTRONIC SOFAMOR DANEK, INC.
- ATLAS® Cable System — MEDTRONIC SOFAMOR DANEK, INC.
- ATLAS® Cable System — MEDTRONIC SOFAMOR DANEK, 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
- Medtronic Sofamor Danek, Inc.
Sources (1)
- FDA UDI 8d2bb997-8e26-4419-a20c-f020f3e12996 35 fields · synced May 30, 2026