Identity
- Trade Name
- Songer® Spinal Cable System FDA UDI
- Generic Name
- Internal spinal fixation system cable FDA UDI
- Device Name
- (1) Ø1.0mm Cable, Single Loop with Crimp, (1) Crimp, Flange, (1) Bar, Round FDA UDI
- Model / Reference
- 400-103 FDA UDI
- Description
- (1) Ø1.0mm Cable, Single Loop with Crimp, (1) Crimp, Flange, (1) Bar, Round FDA UDI
Identifiers
- Catalog Number
- 7825-013S FDA UDI
- Primary DI / UDI-DI
- 00840298704606 FDA UDI
- 510(k) Number
- K941213 FDA UDI
- FDA Product Code
- JDQ FDA UDI
- GMDN Term
- Internal spinal fixation system cable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3010 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
Radiation Sterilization FDA UDI
Category: Internal spinal fixation system cable
Songer® Spinal Cable System by Pioneer Surgical Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Internal spinal fixation system cable.
- VersaTie — Nuvasive, Inc. · Class II
- NILE™ Alternative Fixation System — K2M, INC. · Class II
- VersaTie — Nuvasive, Inc. · Class II
- ATLAS® Cable System — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- NILE™ Alternative Fixation System — K2M, INC. · Class II
- NILE™ Alternative Fixation System — K2M, INC. · Class II
- ATLAS® Cable System — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- ISOLA — Depuy Spine, Inc. · Class II
Cleared under the same submission
K941213 also covers:
- Songer® Spinal Cable System — Pioneer Surgical Technology, Inc.
- Songer® Spinal Cable System — Pioneer Surgical Technology, Inc.
- Songer® Spinal Cable System — Pioneer Surgical Technology, Inc.
- Songer® Spinal Cable System — Pioneer Surgical Technology, Inc.
- Songer® Spinal Cable System — Pioneer Surgical Technology, Inc.
- Songer® Spinal Cable System — Pioneer Surgical Technology, Inc.
- Songer® Spinal Cable System — Pioneer Surgical Technology, Inc.
- Songer® Spinal Cable System — Pioneer Surgical Technology, Inc.
- Songer® Spinal Cable System — Pioneer Surgical Technology, Inc.
- Songer® Spinal Cable System — Pioneer Surgical Technology, Inc.
- Songer® Spinal Cable System — Pioneer Surgical Technology, Inc.
- Songer® Spinal Cable System — Pioneer Surgical Technology, 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
- Pioneer Surgical Technology, Inc.
Sources (1)
- FDA UDI e31e4c44-5174-4fe0-bcee-6bfd37d10474 36 fields · synced May 30, 2026