Songer® Spinal Cable System
GUDID 00846468040932
Torque Driver
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, 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| Primary Device ID | 00846468040932 |
| NIH Device Record Key | ef3a5a1d-2b70-4d8c-a63a-fbe9517d54ab |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Songer® Spinal Cable System |
| Version Model Number | 400-908 |
| 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 | false |
| 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 | 00846468040932 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K922952
FDA Product Code
| JDQ | Cerclage, Fixation |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00846468040932]
Moist Heat or Steam Sterilization
[00846468040932]
Moist Heat or Steam Sterilization
[00846468040932]
Moist Heat or Steam Sterilization
[00846468040932]
Moist Heat or Steam Sterilization
[00846468040932]
Moist Heat or Steam Sterilization
[00846468040932]
Moist Heat or Steam Sterilization
[00846468040932]
Moist Heat or Steam Sterilization
[00846468040932]
Moist Heat or Steam Sterilization
[00846468040932]
Moist Heat or Steam Sterilization
[00846468040932]
Moist Heat or Steam Sterilization
[00846468040932]
Moist Heat or Steam Sterilization
[00846468040932]
Moist Heat or Steam Sterilization
[00846468040932]
Moist Heat or Steam Sterilization
[00846468040932]
Moist Heat or Steam Sterilization
[00846468040932]
Moist Heat or Steam Sterilization
[00846468040932]
Moist Heat or Steam Sterilization
[00846468040932]
Moist Heat or Steam Sterilization
[00846468040932]
Moist Heat or Steam Sterilization
[00846468040932]
Moist Heat or Steam Sterilization
[00846468040932]
Moist Heat or Steam Sterilization
[00846468040932]
Moist Heat or Steam Sterilization
[00846468040932]
Moist Heat or Steam Sterilization
[00846468040932]
Moist Heat or Steam Sterilization
[00846468040932]
Moist Heat or Steam Sterilization
[00846468040932]
Moist Heat or Steam Sterilization
[00846468040932]
Moist Heat or Steam Sterilization
[00846468040932]
Moist Heat or Steam Sterilization
[00846468040932]
Moist Heat or Steam Sterilization
[00846468040932]
Moist Heat or Steam Sterilization
[00846468040932]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-06-02 |
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 |
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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