FDA.reportPublic FDA data

VARIAX

Primary DI
37613327378284
Brand
VARIAX
Company
Stryker Trauma SA
Model
663714M
Catalog number
663714M
Device description
Locking Screw, T6
Published
2018-07-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
HWCScrew, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180500000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180500000VariAx 2 SystemStryker GmbH2018-06-04HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37613327378284PackageGS15In Commercial Distribution
07613327378283PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3761332737828437613327378284
07613327378283076133273782837613327378283

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, non-sterileA small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression. This device must be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length14Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
481999654
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
07613327072631NA3901823901822021-10-27
37613327364102ENDOTRIG1052-61052-62020-09-24
37613327072670VARIAX7038187038182016-09-22
33700586902351AUTOFIX451-0031451-00312015-09-24
33700586903464AUTOFIX451-1136451-11362015-09-24
37613327356503ENDOTRIG106010602018-09-24
37613327362214EDINTRAK406040602017-05-30
37613327072403HOFFMANN4922-1-0024922-1-0022016-09-24
37613327072427HOFFMANN4922-1-0034922-1-0032016-09-24
37613327072687HOFFMANN4922-1-0064922-1-0062016-09-24
37613327072694HOFFMANN4922-1-0074922-1-0072016-09-24
37613154639497NA52-0080452-008042018-09-24
37613154639503NA52-0090452-009042018-09-24
37613154639510NA52-0100452-010042018-09-24
37613154639527NA52-0110552-011052018-09-24
37613154639534NA52-0120452-012042018-09-24
37613154639541NA52-0120552-012052018-09-24
37613154639558NA52-0130452-013042018-09-24
37613154639565NA52-0130652-013062018-09-24
37613154639572NA52-0140452-014042018-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00193982175740ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982175795ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14