Songer® Spinal Cable System 7925-013
GUDID 00840298704613
(1) Ø1.25mm Cable, Single Loop with Crimp, (1) Crimp, Flange, (1) Bar, Round
Pioneer Surgical Technology, Inc.
Internal spinal fixation system cable| Primary Device ID | 00840298704613 |
| NIH Device Record Key | 60583880-9fd3-4271-91f0-6cca0f628271 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Songer® Spinal Cable System |
| Version Model Number | 400-202 |
| Catalog Number | 7925-013 |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840298704613 [Primary] |
| GS1 | 10846468005198 [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 |
[00840298704613]
Moist Heat or Steam Sterilization
[00840298704613]
Moist Heat or Steam Sterilization
[00840298704613]
Moist Heat or Steam Sterilization
[00840298704613]
Moist Heat or Steam Sterilization
[00840298704613]
Moist Heat or Steam Sterilization
[00840298704613]
Moist Heat or Steam Sterilization
[00840298704613]
Moist Heat or Steam Sterilization
[00840298704613]
Moist Heat or Steam Sterilization
[00840298704613]
Moist Heat or Steam Sterilization
[00840298704613]
Moist Heat or Steam Sterilization
[00840298704613]
Moist Heat or Steam Sterilization
[00840298704613]
Moist Heat or Steam Sterilization
[00840298704613]
Moist Heat or Steam Sterilization
[00840298704613]
Moist Heat or Steam Sterilization
[00840298704613]
Moist Heat or Steam Sterilization
[00840298704613]
Moist Heat or Steam Sterilization
[00840298704613]
Moist Heat or Steam Sterilization
[00840298704613]
Moist Heat or Steam Sterilization
[00840298704613]
Moist Heat or Steam Sterilization
[00840298704613]
Moist Heat or Steam Sterilization
[00840298704613]
Moist Heat or Steam Sterilization
[00840298704613]
Moist Heat or Steam Sterilization
[00840298704613]
Moist Heat or Steam Sterilization
[00840298704613]
Moist Heat or Steam Sterilization
[00840298704613]
Moist Heat or Steam Sterilization
[00840298704613]
Moist Heat or Steam Sterilization
[00840298704613]
Moist Heat or Steam Sterilization
[00840298704613]
Moist Heat or Steam Sterilization
[00840298704613]
Moist Heat or Steam Sterilization
[00840298704613]
Moist Heat or Steam Sterilization
[00840298704613]
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 |
Trademark Results [Songer]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SONGER 78426348 2997549 Live/Registered |
PIONEER SURGICAL TECHNOLOGY, INC. 2004-05-27 |
 SONGER 74163022 not registered Dead/Abandoned |
Robert J. Songer 1991-05-02 |
SONGER 74163022 not registered Dead/Abandoned |
Matthew N. Songer 1991-05-02 |
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