QWIX QWX34INSTSET

GUDID 10381780064442

The QWIX positioning and fixation screw are designed to provide speed and precision for challenging surgical situations. They are indicated for fixation of bone fractures or for bone reconstructions. QWIX 3.0 and 4.3 are designed with self-drilling flutes. The compression screw has a non-threaded shaft and a self-tapping screw tip. Instruments are also provided.

NEWDEAL

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 10381780064442
• NIH Device Record Key: 8f373c35-367f-4d49-a0f0-384a31989634
• Commercial Distribution Discontinuation: 2023-03-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: QWIX
• Version Model Number: QWX34INSTSET
• Catalog Number: QWX34INSTSET
• Company DUNS: 536935331
• Company Name: NEWDEAL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780064442 [Primary]
HIBCC	M248QWX34INSTSET1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022599

FDA Product Code

• HTY: PIN, FIXATION, SMOOTH

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[10381780064442]

Moist Heat or Steam Sterilization

[10381780064442]

Moist Heat or Steam Sterilization

[10381780064442]

Moist Heat or Steam Sterilization

[10381780064442]

Moist Heat or Steam Sterilization

[10381780064442]

Moist Heat or Steam Sterilization

[10381780064442]

Moist Heat or Steam Sterilization

[10381780064442]

Moist Heat or Steam Sterilization

[10381780064442]

Moist Heat or Steam Sterilization

[10381780064442]

Moist Heat or Steam Sterilization

[10381780064442]

Moist Heat or Steam Sterilization

[10381780064442]

Moist Heat or Steam Sterilization

[10381780064442]

Moist Heat or Steam Sterilization

[10381780064442]

Moist Heat or Steam Sterilization

[10381780064442]

Moist Heat or Steam Sterilization

[10381780064442]

Moist Heat or Steam Sterilization

[10381780064442]

Moist Heat or Steam Sterilization

[10381780064442]

Moist Heat or Steam Sterilization

[10381780064442]

Moist Heat or Steam Sterilization

[10381780064442]

Moist Heat or Steam Sterilization

[10381780064442]

Moist Heat or Steam Sterilization

[10381780064442]

Moist Heat or Steam Sterilization

[10381780064442]

Moist Heat or Steam Sterilization

[10381780064442]

Moist Heat or Steam Sterilization

[10381780064442]

Moist Heat or Steam Sterilization

[10381780064442]

Moist Heat or Steam Sterilization

[10381780064442]

Moist Heat or Steam Sterilization

[10381780064442]

Moist Heat or Steam Sterilization

[10381780064442]

Moist Heat or Steam Sterilization

[10381780064442]

Moist Heat or Steam Sterilization

[10381780064442]

Moist Heat or Steam Sterilization

[10381780064442]

Moist Heat or Steam Sterilization

[10381780064442]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-05-02
• Device Publish Date: 2015-09-22

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-ON: 2025-03-06 The Newdeal Interphalangeal implant is designed to respect anatomical flexion to achieve fixation of interphalangeal arthrodesis
• 10381780045908 - IPP-ON: 2025-03-06 The Newdeal Interphalangeal implant is designed to respect anatomical flexion to achieve fixation of interphalangeal arthrodesis