Large QWIX QWX57INSTSET

GUDID 10381780064459

The Large QWIX positioning and fixation screws were designed for extremity fixation, to provide speed and precision for challenging surgical situations. The QWIX screw is a cannulated, fully threaded screw with a self-tapping screw tip. Instruments are also provided.

NEWDEAL

General internal orthopaedic fixation system implantation kit
Primary Device ID10381780064459
NIH Device Record Key5e00ff48-f64d-4169-aec2-be15fb6710f0
Commercial Distribution Discontinuation2023-03-31
Commercial Distribution StatusNot in Commercial Distribution
Brand NameLarge QWIX
Version Model NumberQWX57INSTSET
Catalog NumberQWX57INSTSET
Company DUNS536935331
Company NameNEWDEAL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.

Device Identifiers

Device Issuing AgencyDevice ID
GS110381780064459 [Primary]
HIBCCM248QWX57INSTSET1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10381780064459]

Moist Heat or Steam Sterilization

[10381780064459]

Moist Heat or Steam Sterilization

[10381780064459]

Moist Heat or Steam Sterilization

[10381780064459]

Moist Heat or Steam Sterilization

[10381780064459]

Moist Heat or Steam Sterilization

[10381780064459]

Moist Heat or Steam Sterilization

[10381780064459]

Moist Heat or Steam Sterilization

[10381780064459]

Moist Heat or Steam Sterilization

[10381780064459]

Moist Heat or Steam Sterilization

[10381780064459]

Moist Heat or Steam Sterilization

[10381780064459]

Moist Heat or Steam Sterilization

[10381780064459]

Moist Heat or Steam Sterilization

[10381780064459]

Moist Heat or Steam Sterilization

[10381780064459]

Moist Heat or Steam Sterilization

[10381780064459]

Moist Heat or Steam Sterilization

[10381780064459]

Moist Heat or Steam Sterilization

[10381780064459]

Moist Heat or Steam Sterilization

[10381780064459]

Moist Heat or Steam Sterilization

[10381780064459]

Moist Heat or Steam Sterilization

[10381780064459]

Moist Heat or Steam Sterilization

[10381780064459]

Moist Heat or Steam Sterilization

[10381780064459]

Moist Heat or Steam Sterilization

[10381780064459]

Moist Heat or Steam Sterilization

[10381780064459]

Moist Heat or Steam Sterilization

[10381780064459]

Moist Heat or Steam Sterilization

[10381780064459]

Moist Heat or Steam Sterilization

[10381780064459]

Moist Heat or Steam Sterilization

[10381780064459]

Moist Heat or Steam Sterilization

[10381780064459]

Moist Heat or Steam Sterilization

[10381780064459]

Moist Heat or Steam Sterilization

[10381780064459]

Moist Heat or Steam Sterilization

[10381780064459]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-05-02
Device Publish Date2015-09-22

Devices Manufactured by NEWDEAL

M248119510ND1 - I.CO.S®2025-04-28 The measurer is used to measure the 150/200mm K-wire in place and decide the compression screw length to implant. It is placed s
M248119511ND1 - I.CO.S®2025-04-28 The measurer is used to measure the 250mm K-wire in place and decide the compression screw length to implant. It is placed so th
M248119532ND1 - I.CO.S®2025-04-28 The cannulated graduated screwdriver axis, with a 6.0mm diameter tri shank attachment, is used to power implant the 4.0mm compre
M248119536ND1 - I.CO.S®2025-04-28 The external cannulated screwdriver is used to achieve additional dynamic compression by advancing the outer thread head screw i
M248119562ND1 - I.CO.S®2025-04-28 The cannulated screwdriver axis, with a 6.0mm diameter tri shank attachment, is used to implant the 6.5mm compression screws. It
M248119566ND1 - I.CO.S®2025-04-28 The cannulated external screwdriver is used to achieve additional dynamic compression by advancing the outer thread head screw i
10381780045892 - IPP-ON2025-03-06 The Newdeal Interphalangeal implant is designed to respect anatomical flexion to achieve fixation of interphalangeal arthrodesis
10381780045908 - IPP-ON2025-03-06 The Newdeal Interphalangeal implant is designed to respect anatomical flexion to achieve fixation of interphalangeal arthrodesis
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