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Songer® Spinal Cable System

FDA UDI

Class I (US FDA UDI)

by Pioneer Surgical Technology, Inc.

Identity

Trade Name
Songer® Spinal Cable System FDA UDI
Generic Name
Internal spinal fixation system cable tensioner FDA UDI
Device Name
Crimper/Tensioner FDA UDI
Model / Reference
400-120 FDA UDI
Description
Crimper/Tensioner FDA UDI

Identifiers

Catalog Number
7825-111 FDA UDI
Primary DI / UDI-DI
00840298704620 FDA UDI
FDA Product Code
HWN FDA UDI
GMDN Term
Internal spinal fixation system cable tensioner FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Internal spinal fixation system cable tensioner

Songer® Spinal Cable System by Pioneer Surgical Technology, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Internal spinal fixation system cable tensioner.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pioneer Surgical Technology, Inc.

Sources (1)

  • FDA UDI 278a18da-1902-4f48-bacb-cd9473527edf 35 fields · synced May 30, 2026