FDA.reportPublic FDA data

EXPEDIUM

Primary DI
10705034177014
Brand
EXPEDIUM
Company
Medos International Sàrl
Model
189640050
Catalog number
189640050
Device description
EXPEDIUM SPINE SYSTEM CLOSED LATERAL CONNECTOR 6.35 x 50mm
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OSHPedicle screw spinal system, adolescent idiopathic scoliosis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OSHPedicle Screw Spinal System, Adolescent Idiopathic ScoliosisOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034177014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503417701410705034177014

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system connectorAn implantable component of a bone-screw internal spinal fixation system typically in the form of a thin band or small rod with a groove or hole at each end, into which screw heads/rods fit, intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is designed as a transverse connecting element to be attached to corresponding bilateral screw heads or rods; it may also have adjustable length and/or angle and/or allow a small amount of screw/rod movement.

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886705032501GRYPHON Flex2089582089582024-05-17
10705034165448COUGAR1891555141891555142015-09-24
10886705022649RIGIDLOOP2320092320092015-09-01
10886705022656RIGIDLOOP2320112320112015-09-01
10886705022663RIGIDLOOP2320142320142015-09-01
10886705022670RIGIDLOOP2320162320162015-09-01
10886705022687RIGIDLOOP2320172320172015-09-01
10886705022694RIGIDLOOP2320182320182015-09-01
10886705022700RIGIDLOOP2320192320192015-09-01
10886705022717RIGIDLOOP2320212320212015-09-01
10886705022724RIGIDLOOP2320222320222015-09-01
10886705022731RIGIDLOOP2320232320232015-09-01
10886705022755RIGIDLOOP2320282320282015-09-01
10886705022830RIGIDLOOP2320372320372015-09-01
10886705024070RIGIDLOOP2180342180342015-09-01
10886705024094RIGIDLOOP2324472324472015-09-01
10886705024100RIGIDLOOP2324482324482015-09-01
10886705024117RIGIDLOOP2324492324492015-09-01
10886705026012TRUESPAN ORTHOCORD2281512281512016-07-07
10886705026029TRUESPAN ORTHOCORD2281522281522016-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000794675CD HORIZON ESSENCE™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OSH2025-08-14
00763000788018CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OSH2025-07-10
00763000787837CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OSH2025-06-14
00763000788001CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OSH2025-05-15
00763000787813CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OSH2025-05-04
00763000872236CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OSH2025-05-03
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