FDA.reportPublic FDA data

Large QWIX

Primary DI
10381780047964
Brand
Large QWIX
Company
NEWDEAL
Model
121575SND
Catalog number
121575SND
Device description
The QWIX positioning screw is a cannulated screw of 5.5mm diameters. It is fully threaded and has a self-tapping tip. The screw is cannulated to enable the use of a K-Wire for an optimal positioning (1.6mm K-Wire for the 5.5mm screws). It is made from titanium alloy with anodic oxidation, and color coded according to the different diameters. It is delivered sterile.
Published
2017-10-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
K071639000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071639000QWIX POSITIONING SCREWNewdeal Sas2007-07-09HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780047964PrimaryGS10
M248121575SND1SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178004796410381780047964

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, sterile"A small, 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). There are a number of kinds available: 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 across bone fragments."

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dry place.

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
536935331
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780045687K-WIRE115071ND115071ND2017-10-09
10381780045731K-WIRE115110ND115110ND2017-10-09
10381780045755K-WIRE115111ND115111ND2017-10-09
10381780045786K-WIRE115170ND115170ND2017-10-09
10381780045809K-WIRE115171ND115171ND2017-10-09
10381780045847K-WIRE115316ND115316ND2017-10-09
10381780045854K-WIRE115416ND115416ND2017-10-09
10381780041771QWIX®119932ND2017-05-26
10381780042099Hallu®-FIX129930ND2017-05-26
10381780042136Hallu®-FIX129935ND2017-05-26
10381780042266ADVANSYS®169101ND2017-05-26
10381780042273ADVANSYS®169102ND2017-05-26
10381780042280ADVANSYS®169104ND2017-05-26
10381780042327ADVANSYS®188201ND2017-05-26
10381780042334ADVANSYS®188202ND2017-05-26
10381780042419IPP-ON®239000ND2017-05-26
10381780042426IPP-ON®239001ND2017-05-26
10381780042778PANTA®519920ND2017-05-26
10381780042822SURFIX®SET000ND2017-05-26
10381780042839SURFIX®SET100ND2017-05-26

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