DePuy Songer Spinal Cable System 7925013

GUDID 10846468005198

Cable, Single, Ti W/Crmp&Bar, NS,AcroMed

Pioneer Surgical Technology, Inc.

Internal spinal fixation system cable, sterile

Primary Device ID	10846468005198
NIH Device Record Key	c24138b3-2605-49ea-a71d-7162dabf074b
Commercial Distribution Status	In Commercial Distribution
Brand Name	DePuy Songer Spinal Cable System
Version Model Number	400-202
Catalog Number	7925013
Company DUNS	793384496
Company Name	Pioneer Surgical Technology, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(906)226-9909
Email	labeling@resolvesurg.com
Phone	+1(906)226-9909
Email	labeling@resolvesurg.com
Phone	+1(906)226-9909
Email	labeling@resolvesurg.com
Phone	+1(906)226-9909
Email	labeling@resolvesurg.com
Phone	+1(906)226-9909
Email	labeling@resolvesurg.com
Phone	+1(906)226-9909
Email	labeling@resolvesurg.com
Phone	+1(906)226-9909
Email	labeling@resolvesurg.com
Phone	+1(906)226-9909
Email	labeling@resolvesurg.com
Phone	+1(906)226-9909
Email	labeling@resolvesurg.com
Phone	+1(906)226-9909
Email	labeling@resolvesurg.com
Phone	+1(906)226-9909
Email	labeling@resolvesurg.com
Phone	+1(906)226-9909
Email	labeling@resolvesurg.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10846468005198 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K935481
Premarket Notification: K941213

FDA Product Code

JDQ	CERCLAGE, FIXATION

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

[10846468005198]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2021-10-14
Device Publish Date	2015-12-10

On-Brand Devices [DePuy Songer Spinal Cable System]

10846468074743	Cable, Single, Ti W/Cmp&Br, 12-Pk,NS, AM
10846468005365	Bar, Flex, Large, Ti, NS, AcroMed
10846468005358	Bar, Flex, Small, Ti, NS, AcroMed
10846468005341	Bar, Flex, Large, Ti, Strl, AcroMed
10846468005334	Bar, Flex, Small, Ti, Strl, AcroMed
10846468005310	Cable, Double,Loop,Ti W/Cmp,12-Pk,NS,AM
10846468005303	Cable, Single,Ti W/Cmp&Br,12-Pk, Strl,AM
10846468005297	Cable, Dbl, Loop,Ti W/Cmp 12-Pk, Strl,
10846468005280	Cable, ISOLA, Ti, W/Crmp 6-Pack, Strl,
10846468005273	Cable, ISOLA,Ti,W/Crmp 6-Pack,NS,AcroMed
10846468005266	Bar, Flat, Ti 2-Pk, Strl, AcroMed STS
10846468005259	Bar, Flat, Ti 2-Pack, NS, AcroMed
10846468005242	Bar, Round, Ti 2-Pack, Strl, AcroMed STS
10846468005235	Bar, Round, Ti 2-Pack, NS, AcroMed
10846468005228	Crimp, Flange,Ti 2-Pk, Strl, AcroMed STS
10846468005211	Crimp, Flange, Ti 2-Pack, NS, AcroMed
10846468005204	Cable, Single, Ti STS W/Crmp&Bar, Strl
10846468005198	Cable, Single, Ti W/Crmp&Bar, NS,AcroMed
10846468005181	Cable, Dbl,Loop,Ti W/Crmp, Strl, AcroMed
10846468005174	Cable, Dbl,Loop,TI W/Crmp,NS,AcroMed STS
10846468005167	Cable, Single, SS w/Crimp &Bar,12-Pk,NS,
10846468005150	Cable, Double, Loop, SS W/Cmp, 12-Pk,NS,
10846468005143	Cable,Single,SS,W/Crmp &Br, 12-Pk, Strl
10846468005136	Cable, Dbl, Loop,SS W/Cmp 12-Pk, Strl
10846468005129	Cable, ISOLA, SS, W/Crmp 6-Pack, Strl
10846468005112	Cable, ISOLA,SS,W/Crmp 6-Pack,NS,AcroMed
10846468005105	Bar, Flat, SS 2-Pack, Strl, AcroMed
10846468005099	Bar, Flat, SS 2-Pack, NS, AcroMed
10846468005082	Bar, Round, SS 2-Pack, Strl, AcroMed
10846468005075	Bar, Round, SS 2-Pack, NS, AcroMed
10846468005068	Crimp, Flange, SS 2-Pack, Strl, AcroMed
10846468005051	Crimp, Flange, SS 2-Pack, NS, AcroMed
10846468005044	Cable, Single,SS STS w/Crmp&Bar,Strl,Acro
10846468005037	Cable, Single, SS W/Crmp&Bar, NS,AcroMed
10846468005020	Cable, Double, Loop, SS, W/Crmp, Strl,
10846468005013	Cable, Double, Loop, SS, w/Crmp, NS,

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.