FDA.reportPublic FDA data

EXPEDIUM VERSE

Primary DI
10705034403045
Brand
EXPEDIUM VERSE
Company
Medos International Sàrl
Model
199723665
Catalog number
199723665
Device description
EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 6.0 x 65mm
Published
2017-07-25
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
PMLbone cement, posterior screw augmentation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
PMLBone Cement, Posterior Screw AugmentationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160879000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160879000CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw SystemsMedos International Sàrl2016-12-20PML

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034403045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503440304510705034403045

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
10705034581835ROBOTIC INTEGRATION INSTRUMENTS2914-89-0012914890012025-04-17
10705034581842ROBOTIC INTEGRATION INSTRUMENTS2914-89-0022914890022025-04-17
10705034602349ROBOTIC INTEGRATION INSTRUMENTS2914-89-4032914894032025-04-17
10705034602424ROBOTIC INTEGRATION INSTRUMENTS2914-89-4012914894012025-04-17
10705034602462ROBOTIC INTEGRATION INSTRUMENTS2914-89-0002914890002025-04-17
10705034643243VELYS4516110384516110382025-03-28
10705034643250VELYS4516110504516110502025-03-28
10705034643274VELYS4516110214516110212025-03-28
10705034643281VELYS4516110554516110552025-03-28
10705034643298VELYS4516110474516110472025-03-28
10705034643304VELYS4516110464516110462025-03-28
10705034643328VELYS4516110404516110402025-03-28
10705034643342VELYS4516110624516110622025-03-28
10705034643359VELYS4516110454516110452025-03-28
10705034643366VELYS4516110444516110442025-03-28
10705034643373VELYS4516110434516110432025-03-28
10705034643380VELYS4516110414516110412025-03-28
10705034643397VELYS4516110614516110612025-03-28
10705034643403VELYS4516110224516110222025-03-28
10705034643410VELYS4516110234516110232025-03-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889929072943Inertia® Pedicle Screw SystemNEXXT SPINE, LLCMNI2026-08-26
M719IST80030C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80035C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80040C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80045C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80050C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80055C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80060C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80065C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80070C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80075C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80080C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80085C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80090C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80095C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80100C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80105C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80110C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80115C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80120C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80125C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80130C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80135C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80140C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80145C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80150C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719GSIX785D160TiLockGenesys Orthopedics Systems LLCMNI2026-08-17
M719GSIX785D210TiLockGenesys Orthopedics Systems LLCMNI2026-08-17
M719GSIX785D260TiLockGenesys Orthopedics Systems LLCMNI2026-08-17
M719GSIX785D310TiLockGenesys Orthopedics Systems LLCMNI2026-08-17