FDA.reportPublic FDA data

EXPEDIUM

Primary DI
10705034076867
Brand
EXPEDIUM
Company
Medos International Sàrl
Model
179752016
Catalog number
179752016
Device description
EXPEDIUM SPINE SYSTEM HOOK, REDUCED DISTANCE 5.5 x 6.5mm
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
MNHOrthosis, spondylolisthesis spinal fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034076867PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503407686710705034076867

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system hookAn implantable component of a bone-screw internal spinal fixation system that has a curved (hook-shaped) design 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 typically made of metal [e.g., titanium (Ti)] and placed/hooked around the lamina or pedicle of a vertebra, without penetration (i.e., not a screw), to provide a stable connection for the system’s rod; the rod is typically stabilized in the U-shaped hook head with a small lid or 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
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
07290115935615Counter Torque STPREMIA SPINE LTDMNH2026-05-25
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00763000887155CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2026-03-16
00763000992033MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2026-03-14
00841732108134RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732108141RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732108158RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732108165RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732108172RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732108189RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732108196RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732108202RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732108219RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732108226RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732122529RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732122536RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732131835RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732145085RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732145092RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732117860PICASSO II MIS Spinal SystemCTL Medical CorporationMNH2023-09-07
00841732117877PICASSO II MIS Spinal SystemCTL Medical CorporationMNH2023-09-07
00841732117884PICASSO II MIS Spinal SystemCTL Medical CorporationMNH2023-09-07
00841732117891PICASSO II MIS Spinal SystemCTL Medical CorporationMNH2023-09-07
00841732117907PICASSO II MIS Spinal SystemCTL Medical CorporationMNH2023-09-07
00841732117914PICASSO II MIS Spinal SystemCTL Medical CorporationMNH2023-09-07
00840996188715THUNDERBOLT Minimally Invasive Pedicle Screw SystemsChoice Spine, LPMNH2023-02-03
088000333584424CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNH2018-08-17
00841732118959PICASSO II MIS Spinal SystemCTL Medical CorporationMNH2017-08-08
00841732118966PICASSO II MIS Spinal SystemCTL Medical CorporationMNH2017-08-08
00841732118973PICASSO II MIS Spinal SystemCTL Medical CorporationMNH2017-08-08