FDA.reportPublic FDA data

VIPER

Primary DI
10705034282909
Brand
VIPER
Company
Medos International Sàrl
Model
186727950
Catalog number
186727950
Device description
VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 x 9 x 50mm
Published
2017-05-02
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
10705034282909PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503428290910705034282909

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
10886705001309RIGIDFIX BIOCRYL2108162108162015-09-01
10705034647302CROSSNAV CONDUIT3010-21-9963010219962026-07-09
10705034647319CROSSNAV CONDUIT3010-21-9993010219992026-07-09
10705034647326CROSSNAV CONDUIT3010-21-3323010213322026-07-09
10705034647333CROSSNAV CONDUIT3010-21-3313010213312026-07-09
10705034647340CROSSNAV CONDUIT3010-21-2103010212102026-07-09
10705034647357CROSSNAV CONDUIT3010-21-2113010212112026-07-09
10705034647364CROSSNAV CONDUIT3010-21-2123010212122026-07-09
10705034647371CROSSNAV CONDUIT3010-21-2133010212132026-07-09
10705034647388CROSSNAV CONDUIT3010-21-2143010212142026-07-09
10705034647395CROSSNAV CONDUIT3010-21-2153010212152026-07-09
10705034647418CROSSNAV CONDUIT3010-21-2083010212082026-07-09
10705034647425CROSSNAV CONDUIT3010-21-2093010212092026-07-09
10705034647432CROSSNAV CONDUIT3010-21-3203010213202026-07-09
10705034647449CROSSNAV CONDUIT3010-21-3153010213152026-07-09
10705034647456CROSSNAV CONDUIT3010-21-9983010219982026-07-09
10705034647463N/A3010-21-3403010213402026-07-09
10705034647470CROSSNAV CONDUIT3010-21-3013010213012026-07-09
10705034647487CROSSNAV CONDUIT3010-21-3033010213032026-07-09
10705034647494CROSSNAV CONDUIT3010-21-3143010213142026-07-09

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04047844129623DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
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