FDA.reportPublic FDA data

DePuy Songer Spinal Cable System

Primary DI
10846468074743
Brand
DePuy Songer Spinal Cable System
Company
Pioneer Surgical Technology, Inc.
Model
400-215
Catalog number
7925014
Device description
Cable, Single, Ti W/Cmp&Br, 12-Pk,NS, AM
Published
2016-10-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JDQCERCLAGE, FIXATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDQCerclage, FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K935481000
K941213000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K935481000SPONGER CABLE SYSTEM, MODIFICATIONPioneer Surgical Technology1994-01-26JDQ
K941213000SONGER CABLE SYSTEMPioneer Surgical Technology1994-04-19JDQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10846468074743PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084646807474310846468074743

GMDN Terms#

Term, Definition table
TermDefinition
Internal spinal fixation system cable, sterileA sterile implantable fixation device designed to apply a force to a series of vertebrae to correct scoliosis (lateral curvature of the spine) or other spinal conditions. The device is typically made of braided medical grade titanium (Ti) and stainless steel alloy of various lengths and designs (e.g., it may be supplied with or without attached fasteners). The cable is tightened with a tension device and is fastened or crimped at each eye-type screw.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
793384496
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

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Primary DI, Brand, Model table
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00840298701605CODA™ Anterior Cervical Plate System58-102202034S1022-02-034S2023-06-26
00840298701612CODA™ Anterior Cervical Plate System58-102202036S1022-02-036S2023-06-26
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00840298701650CODA™ Anterior Cervical Plate System58-102202044S1022-02-044S2023-06-26

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