FDA.reportPublic FDA data

EXPEDIUM VERSE

Primary DI
10705034442563
Brand
EXPEDIUM VERSE
Company
Medos International Sàrl
Model
199721470
Catalog number
199721470
Device description
EXPEDIUM VERSE SPINE SYSTEM POLYAXIAL SCREW 5.5 4.35 x 70mm
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
MNIORTHOSIS, SPINAL PEDICLE FIXATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034442563PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503444256310705034442563

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a slotted head intended to be used for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is available in various types, including pedicle and transfacet, and is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities.

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
10705034165448COUGAR1891555141891555142015-09-24
10705034189017VG22733401002733401002016-12-31
10705034192802SUMMIT2746280002746280002016-12-31
10705034195278DISCOVERY2757200002757200002016-12-31
10705034199368EXPEDIUM2797224602797224602016-12-31
10705034224817UNIPLATE2897110002897110002016-12-31
10705034204246KEYSTONE2821040002821040002016-11-18
10705034060835BENGAL1773061221773061222015-09-24
10705034060866BENGAL1773061281773061282015-09-24
10705034161372COUGAR1891304101891304102015-09-24
10705034162973COUGAR1891404141891404142015-09-24
10705034163345COUGAR1891408121891408122015-09-24
10705034163369COUGAR1891408141891408142015-09-24
10705034163383COUGAR1891408161891408162015-09-24
10705034163499COUGAR1891451141891451142015-09-24
10705034163581COUGAR1891452101891452102015-09-24
10705034163604COUGAR1891452121891452122015-09-24
10705034163628COUGAR1891452141891452142015-09-24
10705034164168COUGAR1891458161891458162015-09-24
10705034164212COUGAR1891501081891501082015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290115935615Counter Torque STPREMIA SPINE LTDMNI2026-05-25
00763000887131CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-03-16
00763000887162CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-03-16
00763000887179CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-03-16
00841732117860PICASSO IICTL Medical CorporationMNI2023-09-07
00841732117877PICASSO IICTL Medical CorporationMNI2023-09-07
00841732117884PICASSO IICTL Medical CorporationMNI2023-09-07
00841732117891PICASSO IICTL Medical CorporationMNI2023-09-07
00841732117907PICASSO IICTL Medical CorporationMNI2023-09-07
00841732117914PICASSO IICTL Medical CorporationMNI2023-09-07
00841732118959PICASSO IICTL Medical CorporationMNI2017-08-08
00841732118966PICASSO IICTL Medical CorporationMNI2017-08-08
00841732118973PICASSO IICTL Medical CorporationMNI2017-08-08
00841732118980PICASSO IICTL Medical CorporationMNI2017-08-08
00841732119017PICASSO IICTL Medical CorporationMNI2017-08-08
00841732119024PICASSO IICTL Medical CorporationMNI2017-08-08
00841732119031PICASSO IICTL Medical CorporationMNI2017-08-08
00841732119048PICASSO IICTL Medical CorporationMNI2017-08-08
00841732119055PICASSO IICTL Medical CorporationMNI2017-08-08
00841732119062PICASSO IICTL Medical CorporationMNI2017-08-08
00841732119079PICASSO IICTL Medical CorporationMNI2017-08-08
088000333846944CIS VANE SPINE SYSTEMALPHA AI CO.,LTD.MNI2016-10-28
088000333847174CIS VANE SPINE SYSTEMALPHA AI CO.,LTD.MNI2016-10-28
088000333847244CIS VANE SPINE SYSTEMALPHA AI CO.,LTD.MNI2016-10-28
088000333847484CIS VANE SPINE SYSTEMALPHA AI CO.,LTD.MNI2016-10-28
088000333847554CIS VANE SPINE SYSTEMALPHA AI CO.,LTD.MNI2016-10-28
088000333847624CIS VANE SPINE SYSTEMALPHA AI CO.,LTD.MNI2016-10-28
088000333847794CIS VANE SPINE SYSTEMALPHA AI CO.,LTD.MNI2016-10-28
088000333847864CIS VANE SPINE SYSTEMALPHA AI CO.,LTD.MNI2016-10-28
088000333850974CIS VANE SPINE SYSTEMALPHA AI CO.,LTD.MNI2015-12-11