FDA.reportPublic FDA data

ATLAS® Cable System

Primary DI
00673978047966
Brand
ATLAS® Cable System
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
826-211
Device description
CABLE 826-211 DBL W INTEGRAL CRIMP TI
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
00673978047966PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00673978047966006739780479666739780479660673978047966

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
00199150073504Medtronic Reusable InstrumentsEX12250012026-05-25
00199150071685Medtronic Reusable InstrumentsEX02261402026-05-24
00199150071692Medtronic Reusable InstrumentsEX02261502026-05-24
00199150071708Medtronic Reusable InstrumentsEX02261602026-05-24
00199150071715Medtronic Reusable InstrumentsEX02261702026-05-24
00199150071722Medtronic Reusable InstrumentsEX02261802026-05-24
00199150071739Medtronic Reusable InstrumentsEX02261902026-05-24
00199150071746Medtronic Reusable InstrumentsEX02262002026-05-24
00199150071753Medtronic Reusable InstrumentsEX02260402026-05-24
00199150071760Medtronic Reusable InstrumentsEX02260502026-05-24
00199150071777Medtronic Reusable InstrumentsEX02260602026-05-24
00199150071784Medtronic Reusable InstrumentsEX02260702026-05-24
00199150071791Medtronic Reusable InstrumentsEX02260802026-05-24
00199150071807Medtronic Reusable InstrumentsEX02260902026-05-24
00199150071814Medtronic Reusable InstrumentsEX02261002026-05-24
00199150072057Medtronic Reusable InstrumentsX65500232026-05-23
00199150072064Medtronic Reusable InstrumentsX65500242026-05-23
00199150072576Medtronic Reusable InstrumentsEX02260222026-05-23
00199150074532Medtronic Reusable InstrumentsX12250022026-05-22
00199150074549Medtronic Reusable InstrumentsX12250032026-05-22

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 (U.S.A.) LPLRN2019-08-29
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