FDA.reportPublic FDA data

ATLAS® Cable System

Primary DI
00673978047898
Brand
ATLAS® Cable System
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
826-013
Device description
CABLE 826-013 SNGL CBL WINTGL CRMP SS
Published
2016-04-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRNWire, surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRNWire, SurgicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K892651000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K892651000SONGER WIRING SYSTEMDanek Medical, Inc.1989-07-25LRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00673978047898PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00673978047898006739780478986739780478980673978047898

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(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
830350380
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00643169016798Medtronic Reusable InstrumentsX06110012022-11-27
00643169016804Medtronic Reusable InstrumentsX06110022022-11-27
00673978816241Medtronic Reusable InstrumentsX06990402022-11-27
00613994423559N/AX07072142022-11-14
00613994423566N/AX07072152022-11-14
00613994423573N/AX07072162022-11-14
00613994423603N/AX07072192022-11-14
00643169588219Medtronic Resuable InstrumentsX08108352022-11-14
00643169860940Medtronic Resuable InstrumentsX07160322022-11-14
00643169860957Medtronic Resuable InstrumentsX07160332022-11-14
00613994107169Medtronic Reusable InstrumentsX08050732022-10-07
00613994230676Medtronic Reusable InstrumentsX07061412022-10-07
00613994404510Medtronic Reusable InstrumentsX07061942022-10-07
00613994507129Medtronic Reusable InstrumentsX08081362022-10-07
00613994507150Medtronic Reusable InstrumentsX08081392022-10-07
00613994507174Medtronic Reusable InstrumentsX08081412022-10-07
00613994838797Medtronic Reusable InstrumentsX06102712022-10-07
00613994838803Medtronic Reusable InstrumentsX06102702022-10-07
00613994838841Medtronic Reusable InstrumentsX06102662022-10-07
00613994866011Medtronic Reusable InstrumentsX08108102022-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840124516496FibFixFUSION ORTHOPEDICS, LLCLRN2026-04-09
00840124516502FibFixFUSION ORTHOPEDICS, LLCLRN2026-04-09
00840124517509FibFixFUSION ORTHOPEDICS, LLCLRN2026-04-09
00840124517516FibFixFUSION ORTHOPEDICS, LLCLRN2026-04-09
00840124518551FibFixFUSION ORTHOPEDICS, LLCLRN2026-04-09
00840124524712FuzeFix Max FTFUSION ORTHOPEDICS, LLCLRN2025-11-03
00840124521599FuzeFix Max FTFUSION ORTHOPEDICS, LLCLRN2025-09-17
00840124521674FuzeFix Max FTFUSION ORTHOPEDICS, LLCLRN2025-09-17
00840124514843FuzeRightFUSION ORTHOPEDICS, LLCLRN2025-01-07
00840124514782LapiLockFUSION ORTHOPEDICS, LLCLRN2025-01-06
00840124514799LapiLockFUSION ORTHOPEDICS, LLCLRN2025-01-06
00840124514805LapiLockFUSION ORTHOPEDICS, LLCLRN2025-01-06
00840124514812LapiLockFUSION ORTHOPEDICS, LLCLRN2025-01-06
00840124514829LapiLockFUSION ORTHOPEDICS, LLCLRN2025-01-06
00840124514836LapiLockFUSION ORTHOPEDICS, LLCLRN2025-01-06
00673978047690ATLAS® Cable SystemMEDTRONIC SOFAMOR DANEK, INC.LRN2021-12-19
M20922794K-Wire with stop 1.0mmBIOPRO, INC.LRN2020-08-05
20705034764051NASynthes GmbHLRN2019-08-29
H9812920200NASYNTHES (U.S.A.) LPLRN2019-08-29
10603295210320NADEPUY INTERNATIONAL LTDLRN2018-09-24
00889024035546NAZimmer, Inc.LRN2017-09-26
M209206660K-Wire with stop 1.0mmBIOPRO, INC.LRN2017-08-13
10603295067740CONTROLDEPUY ORTHOPAEDICS, INC.LRN2017-07-21
20673978047885ATLAS® Cable SystemMEDTRONIC SOFAMOR DANEK, INC.LRN2016-06-25
20673978047977ATLAS® Cable SystemMEDTRONIC SOFAMOR DANEK, INC.LRN2016-06-25
20673978048004ATLAS® Cable SystemMEDTRONIC SOFAMOR DANEK, INC.LRN2016-06-25
04546540568083Dall-MilesHowmedica Osteonics Corp.LRN2015-09-24
04546540568090Dall-MilesHowmedica Osteonics Corp.LRN2015-09-24
04546540568106Dall-MilesHowmedica Osteonics Corp.LRN2015-09-24
04546540568113Dall-MilesHowmedica Osteonics Corp.LRN2015-09-24