FDA.reportPublic FDA data

Songer® Spinal Cable System

Primary DI
00846468040857
Brand
Songer® Spinal Cable System
Company
Pioneer Surgical Technology, Inc.
Model
400-654
Device description
Crimp, Flange, SS, 2pk
Published
2016-06-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDQCerclage, Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDQCerclage, FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K922952000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K922952000SONGER CABLE SYSTEMPioneer Surgical Technology1993-02-23JDQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846468040857PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846468040857008464680408578464680408570846468040857

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

Contacts#

Phone, Email table
PhoneEmail
+1(906)226-9909labeling@resolvesurg.com
+1(906)226-9909regulatory@exalta.com

Regulatory Flags#

DUNS number
793384496
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00840298703708CODA™ Anterior Cervical Plate System58-202230014S2022-30-014S2023-06-28
00840298701445CODA™ Anterior Cervical Plate System58-102201010S1022-01-010S2023-06-26
00840298701452CODA™ Anterior Cervical Plate System58-102201012S1022-01-012S2023-06-26
00840298701469CODA™ Anterior Cervical Plate System58-102201014S1022-01-014S2023-06-26
00840298701476CODA™ Anterior Cervical Plate System58-102201016S1022-01-016S2023-06-26
00840298701490CODA™ Anterior Cervical Plate System58-102201020S1022-01-020S2023-06-26
00840298701506CODA™ Anterior Cervical Plate System58-102201022S1022-01-022S2023-06-26
00840298701520CODA™ Anterior Cervical Plate System58-102201026S1022-01-026S2023-06-26
00840298701537CODA™ Anterior Cervical Plate System58-102201028S1022-01-028S2023-06-26
00840298701544CODA™ Anterior Cervical Plate System58-102201030S1022-01-030S2023-06-26
00840298701568CODA™ Anterior Cervical Plate System58-102202026S1022-02-026S2023-06-26
00840298701582CODA™ Anterior Cervical Plate System58-102202030S1022-02-030S2023-06-26
00840298701599CODA™ Anterior Cervical Plate System58-102202032S1022-02-032S2023-06-26
00840298701605CODA™ Anterior Cervical Plate System58-102202034S1022-02-034S2023-06-26
00840298701612CODA™ Anterior Cervical Plate System58-102202036S1022-02-036S2023-06-26
00840298701629CODA™ Anterior Cervical Plate System58-102202038S1022-02-038S2023-06-26
00840298701636CODA™ Anterior Cervical Plate System58-102202040S1022-02-040S2023-06-26
00840298701643CODA™ Anterior Cervical Plate System58-102202042S1022-02-042S2023-06-26
00840298701650CODA™ Anterior Cervical Plate System58-102202044S1022-02-044S2023-06-26

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