Songer® Spinal Cable System 7925-018S

GUDID 00840298704378

(1) Ø1.25mm Small Cable, Double Loop with Crimps (Flexible Bar)

Pioneer Surgical Technology, Inc.

Internal spinal fixation system cable
Primary Device ID00840298704378
NIH Device Record Keyd2d079be-3b32-4753-8af5-dc8f88f76120
Commercial Distribution StatusIn Commercial Distribution
Brand NameSonger® Spinal Cable System
Version Model Number400-216
Catalog Number7925-018S
Company DUNS793384496
Company NamePioneer Surgical Technology, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(386)418-8888
Emaillabelrequest@resolvesurg.com
Phone+1(386)418-8888
Emaillabelrequest@resolvesurg.com
Phone+1(386)418-8888
Emaillabelrequest@resolvesurg.com
Phone+1(386)418-8888
Emaillabelrequest@resolvesurg.com
Phone+1(386)418-8888
Emaillabelrequest@resolvesurg.com
Phone+1(386)418-8888
Emaillabelrequest@resolvesurg.com
Phone+1(386)418-8888
Emaillabelrequest@resolvesurg.com
Phone+1(386)418-8888
Emaillabelrequest@resolvesurg.com
Phone+1(386)418-8888
Emaillabelrequest@resolvesurg.com
Phone+1(386)418-8888
Emaillabelrequest@resolvesurg.com
Phone+1(386)418-8888
Emaillabelrequest@resolvesurg.com
Phone+1(386)418-8888
Emaillabelrequest@resolvesurg.com
Phone+1(386)418-8888
Emaillabelrequest@resolvesurg.com
Phone+1(386)418-8888
Emaillabelrequest@resolvesurg.com
Phone+1(386)418-8888
Emaillabelrequest@resolvesurg.com
Phone+1(386)418-8888
Emaillabelrequest@resolvesurg.com
Phone+1(386)418-8888
Emaillabelrequest@resolvesurg.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100840298704378 [Primary]
GS110846468005334 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDQCerclage, fixation

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00840298704378]

Radiation Sterilization


[00840298704378]

Radiation Sterilization


[00840298704378]

Radiation Sterilization


[00840298704378]

Radiation Sterilization


[00840298704378]

Radiation Sterilization


[00840298704378]

Radiation Sterilization


[00840298704378]

Radiation Sterilization


[00840298704378]

Radiation Sterilization


[00840298704378]

Radiation Sterilization


[00840298704378]

Radiation Sterilization


[00840298704378]

Radiation Sterilization


[00840298704378]

Radiation Sterilization


[00840298704378]

Radiation Sterilization


[00840298704378]

Radiation Sterilization


[00840298704378]

Radiation Sterilization


[00840298704378]

Radiation Sterilization


[00840298704378]

Radiation Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-02
Device Publish Date2024-08-23

On-Brand Devices [Songer® Spinal Cable System]

00846468061913CUTTER, CABLE, SPINAL
00846468061906Nerve Hook, Spinal
00846468061890Nerve Hook, Spinal
00846468061883Inserter Crimp
00846468061876Crimper II, Assembly Spinal
00846468047962Songer Cable Instrument Case
00846468040994STERILIZATION CASE
00846468040932Torque Driver
00846468040888Cutter
00846468040871Nerve Hook
00846468040864Crimp, Flange, Ti, 2pk
00846468040857Crimp, Flange, SS, 2pk
00846468040840Cable, Double Loop, Ti, w/Crimp
00846468040833Cable, Double Loop, SS, w/Crimp
00846468040826Cable, Single Loop, Ti, w/Crimp
00846468040819Cable, Single Loop, SS, w/Crimp
00846468040802Crimp Inserter
00846468040796Tensioner Crimper
00846468030322Crimp, Flange, SS 2-Pack
00846468030315Cable, Double, Loop, SS W/Crimp, 1 PK
00846468030308Cable, Single, Loop, SS W/Crimp, 1 PK
00846468023614Crimp, Flange, Ti 2-Pack
00846468023607Cable, Double, Loop, Ti W/Crimp 1 PK
00846468023591Cable, Single, Loop Ti W/Crimp, 1 PK
00846468016005Instrument 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
00840298704620Crimper/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
SONGER
78426348 2997549 Live/Registered
PIONEER SURGICAL TECHNOLOGY, INC.
2004-05-27
SONGER
SONGER
74163022 not registered Dead/Abandoned
Robert J. Songer
1991-05-02
SONGER
SONGER
74163022 not registered Dead/Abandoned
Matthew N. Songer
1991-05-02

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