Songer® Spinal Cable System 7825-014

GUDID 00840298704668

(1) Ø1.0mm Cable, Single Loop with Crimp, (1) Crimp, Flange, (1) Bar, Round

Pioneer Surgical Technology, Inc.

Internal spinal fixation system cable

• Primary Device ID: 00840298704668
• NIH Device Record Key: 0fa45ce3-6d5e-4495-b758-122209ce309a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Songer® Spinal Cable System
• Version Model Number: 400-115
• Catalog Number: 7825-014
• Company DUNS: 793384496
• Company Name: Pioneer Surgical Technology, Inc.
• Device Count: 1
• DM Exempt: true
• 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(386)418-8888
• Email: labelrequest@resolvesurg.com
• Phone: +1(386)418-8888
• Email: labelrequest@resolvesurg.com
• Phone: +1(386)418-8888
• Email: labelrequest@resolvesurg.com
• Phone: +1(386)418-8888
• Email: labelrequest@resolvesurg.com
• Phone: +1(386)418-8888
• Email: labelrequest@resolvesurg.com
• Phone: +1(386)418-8888
• Email: labelrequest@resolvesurg.com
• Phone: +1(386)418-8888
• Email: labelrequest@resolvesurg.com
• Phone: +1(386)418-8888
• Email: labelrequest@resolvesurg.com
• Phone: +1(386)418-8888
• Email: labelrequest@resolvesurg.com
• Phone: +1(386)418-8888
• Email: labelrequest@resolvesurg.com
• Phone: +1(386)418-8888
• Email: labelrequest@resolvesurg.com
• Phone: +1(386)418-8888
• Email: labelrequest@resolvesurg.com
• Phone: +1(386)418-8888
• Email: labelrequest@resolvesurg.com
• Phone: +1(386)418-8888
• Email: labelrequest@resolvesurg.com
• Phone: +1(386)418-8888
• Email: labelrequest@resolvesurg.com
• Phone: +1(386)418-8888
• Email: labelrequest@resolvesurg.com
• Phone: +1(386)418-8888
• Email: labelrequest@resolvesurg.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840298704668 [Primary]
GS1	10846468005167 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K941213

FDA Product Code

• JDQ: Cerclage, fixation

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00840298704668]

Moist Heat or Steam Sterilization

[00840298704668]

Moist Heat or Steam Sterilization

[00840298704668]

Moist Heat or Steam Sterilization

[00840298704668]

Moist Heat or Steam Sterilization

[00840298704668]

Moist Heat or Steam Sterilization

[00840298704668]

Moist Heat or Steam Sterilization

[00840298704668]

Moist Heat or Steam Sterilization

[00840298704668]

Moist Heat or Steam Sterilization

[00840298704668]

Moist Heat or Steam Sterilization

[00840298704668]

Moist Heat or Steam Sterilization

[00840298704668]

Moist Heat or Steam Sterilization

[00840298704668]

Moist Heat or Steam Sterilization

[00840298704668]

Moist Heat or Steam Sterilization

[00840298704668]

Moist Heat or Steam Sterilization

[00840298704668]

Moist Heat or Steam Sterilization

[00840298704668]

Moist Heat or Steam Sterilization

[00840298704668]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-02
• Device Publish Date: 2024-08-23

On-Brand Devices [Songer® Spinal Cable System]

• 00846468061913: CUTTER, CABLE, SPINAL
• 00846468061906: Nerve Hook, Spinal
• 00846468061890: Nerve Hook, Spinal
• 00846468061883: Inserter Crimp
• 00846468061876: Crimper II, Assembly Spinal
• 00846468047962: Songer Cable Instrument Case
• 00846468040994: STERILIZATION CASE
• 00846468040932: Torque Driver
• 00846468040888: Cutter
• 00846468040871: Nerve Hook
• 00846468040864: Crimp, Flange, Ti, 2pk
• 00846468040857: Crimp, Flange, SS, 2pk
• 00846468040840: Cable, Double Loop, Ti, w/Crimp
• 00846468040833: Cable, Double Loop, SS, w/Crimp
• 00846468040826: Cable, Single Loop, Ti, w/Crimp
• 00846468040819: Cable, Single Loop, SS, w/Crimp
• 00846468040802: Crimp Inserter
• 00846468040796: Tensioner Crimper
• 00846468030322: Crimp, Flange, SS 2-Pack
• 00846468030315: Cable, Double, Loop, SS W/Crimp, 1 PK
• 00846468030308: Cable, Single, Loop, SS W/Crimp, 1 PK
• 00846468023614: Crimp, Flange, Ti 2-Pack
• 00846468023607: Cable, Double, Loop, Ti W/Crimp 1 PK
• 00846468023591: Cable, Single, Loop Ti W/Crimp, 1 PK
• 00846468016005: Instrument Case
• 00840298704675: (1) Ø1.0mm Cable, Single Loop with Crimp, (1) Crimp, Flange, (1) Bar, Round
• 00840298704668: (1) Ø1.0mm Cable, Single Loop with Crimp, (1) Crimp, Flange, (1) Bar, Round
• 00840298704651: (1) Ø1.0mm Cable, Double Loop with Crimp, (2) Crimp, Flange
• 00840298704620: Crimper/Tensioner
• 00840298704613: (1) Ø1.25mm Cable, Single Loop with Crimp, (1) Crimp, Flange, (1) Bar, Round
• 00840298704606: (1) Ø1.0mm Cable, Single Loop with Crimp, (1) Crimp, Flange, (1) Bar, Round
• 00840298704569: (1) Ø1.0mm Cable, Double Loop with Crimp, (2) Crimp, Flange
• 00840298704545: (6) Ø1.25mm Cable, ISOLA with Crimp, (10) Crimp, Flange
• 00840298704521: (6) Ø1.0mm Cable, ISOLA with Crimp, (10) Crimp, Flange
• 00840298704491: (2) Crimp, Flange
• 00840298704477: (2) Crimp, Flange
• 00840298704460: (2) Bar, Round
• 00840298704446: (2) Bar, Round
• 00840298704422: (2) Bar, Flat
• 00840298704415: (2) Bar, Flat
• 00840298704385: (1) Ø1.25mm Single Loop Cable with Crimp, (1) Crimp, Flange, (1) Bar, Round
• 00840298704378: (1) Ø1.25mm Small Cable, Double Loop with Crimps (Flexible Bar)
• 00840298704361: (1) Ø1.25mm Large Cable, Double Loop with Crimps (Flexible Bar)
• 00840298704354: (1) Ø1.25mm Large Cable, Double Loop with Crimps (Flexible Bar)
• 00840298704347: (1) Ø1.25mm Small Cable, Double Loop with Crimps (Flexible Bar)
• 00840298704583: (1) Ø1.25mm Cable, Double Loop with Crimp, (2) Crimp, Flange