← Back to catalogue

DePuy Songer Spinal Cable System

FDA UDI

Class II (US FDA UDI)

by Pioneer Surgical Technology, Inc.

Identity

Trade Name
DePuy Songer Spinal Cable System FDA UDI
Generic Name
Internal spinal fixation system cable FDA UDI
Device Name
Cable, ISOLA,Ti,W/Crmp 6-Pack,NS,AcroMed FDA UDI
Model / Reference
400-210 FDA UDI
Description
Cable, ISOLA,Ti,W/Crmp 6-Pack,NS,AcroMed FDA UDI

Identifiers

Catalog Number
7925021 FDA UDI
Primary DI / UDI-DI
10846468005273 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
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

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

Cleared under the same submission

K941213 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Pioneer Surgical Technology, Inc.

Sources (1)

  • FDA UDI 71b10381-6658-4381-893d-e0ffbca8db0d 37 fields · synced Jun 8, 2026