FDA.reportPublic FDA data

EXPEDIUM

Primary DI
10705034085371
Brand
EXPEDIUM
Company
Medos International Sàrl
Model
179902830
Catalog number
179902830
Device description
EXPEDIUM SPINE SYSTEM MONOAXIAL SCREW 6.35 x 8 x 30mm
Published
2015-09-24
Public version status
Update
Distribution status
Not 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
10705034085371PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503408537110705034085371

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

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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