FDA.reportPublic FDA data

EXPEDIUM

Primary DI
10705034032115
Brand
EXPEDIUM
Company
Medos International Sàrl
Model
175461005
Catalog number
175461005
Device description
EXPEDIUM SPINE SYSTEM SPINAL WIRE, DOUBLE Diameter 1.0mm
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NKBOrthosis, spinal pedicle fixation, for degenerative disc disease

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101070000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101070000EXPEDIUM SPINE SYSTEMMedos International SARL2010-08-31NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034032115PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503403211510705034032115

GMDN Terms#

Term, Definition table
TermDefinition
Internal spinal fixation system cableAn 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

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
482661753
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886705032266NA2423332423332026-07-22
10886705001309RIGIDFIX BIOCRYL2108162108162015-09-01
10705034647302CROSSNAV CONDUIT3010-21-9963010219962026-07-09
10705034647319CROSSNAV CONDUIT3010-21-9993010219992026-07-09
10705034647326CROSSNAV CONDUIT3010-21-3323010213322026-07-09
10705034647333CROSSNAV CONDUIT3010-21-3313010213312026-07-09
10705034647340CROSSNAV CONDUIT3010-21-2103010212102026-07-09
10705034647357CROSSNAV CONDUIT3010-21-2113010212112026-07-09
10705034647364CROSSNAV CONDUIT3010-21-2123010212122026-07-09
10705034647371CROSSNAV CONDUIT3010-21-2133010212132026-07-09
10705034647388CROSSNAV CONDUIT3010-21-2143010212142026-07-09
10705034647395CROSSNAV CONDUIT3010-21-2153010212152026-07-09
10705034647418CROSSNAV CONDUIT3010-21-2083010212082026-07-09
10705034647425CROSSNAV CONDUIT3010-21-2093010212092026-07-09
10705034647432CROSSNAV CONDUIT3010-21-3203010213202026-07-09
10705034647449CROSSNAV CONDUIT3010-21-3153010213152026-07-09
10705034647456CROSSNAV CONDUIT3010-21-9983010219982026-07-09
10705034647463N/A3010-21-3403010213402026-07-09
10705034647470CROSSNAV CONDUIT3010-21-3013010213012026-07-09
10705034647487CROSSNAV CONDUIT3010-21-3033010213032026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841732169272PICASSO MIS Spinal SystemCTL Medical CorporationNKB2026-07-24
00841732169289PICASSO MIS Spinal SystemCTL Medical CorporationNKB2026-07-24
00841732169296PICASSO MIS Spinal SystemCTL Medical CorporationNKB2026-07-24
00841732169302PICASSO MIS Spinal SystemCTL Medical CorporationNKB2026-07-24
00841732169319PICASSO MIS Spinal SystemCTL Medical CorporationNKB2026-07-24
10888857598164Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598171Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598188Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598195Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598201Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598218Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598225Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598232Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598249Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598256Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598263Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598270Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598287Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598294Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598300Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598317Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598324Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598331Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598348Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598355Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598362Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598379Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598386Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598393Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598409Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24