DePuy Songer Spinal Cable System 7925015

GUDID 10846468005211

Crimp, Flange, Ti 2-Pack, NS, AcroMed

Pioneer Surgical Technology, Inc.

Internal spinal fixation system cable, sterile Internal spinal fixation system cable, sterile Internal spinal fixation system cable, sterile Internal spinal fixation system cable, sterile Internal spinal fixation system cable, sterile Internal spinal fixation system cable, sterile Internal spinal fixation system cable, sterile Internal spinal fixation system cable, sterile Internal spinal fixation system cable, sterile Internal spinal fixation system cable, sterile Internal spinal fixation system cable, sterile Internal spinal fixation system cable, sterile Internal spinal fixation system cable, sterile Internal spinal fixation system cable, sterile Internal spinal fixation system cable, sterile Internal spinal fixation system cable, sterile Internal spinal fixation system cable Internal spinal fixation system cable Internal spinal fixation system cable Internal spinal fixation system cable Internal spinal fixation system cable Internal spinal fixation system cable Internal spinal fixation system cable Internal spinal fixation system cable Internal spinal fixation system cable Internal spinal fixation system cable Internal spinal fixation system cable Internal spinal fixation system cable Internal spinal fixation system cable Internal spinal fixation system cable Internal spinal fixation system cable Internal spinal fixation system cable Internal spinal fixation system cable Internal spinal fixation system cable Internal spinal fixation system cable Internal spinal fixation system cable Internal spinal fixation system cable Internal spinal fixation system cable Internal spinal fixation system cable Internal spinal fixation system cable Internal spinal fixation system cable Internal spinal fixation system cable Internal spinal fixation system cable Internal spinal fixation system cable Internal spinal fixation system cable Internal spinal fixation system cable

• Primary Device ID: 10846468005211
• NIH Device Record Key: 15eeca5a-0c44-43f6-9fcd-0ce05eba9027
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DePuy Songer Spinal Cable System
• Version Model Number: 400-204
• Catalog Number: 7925015
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10846468005211 [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

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

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,