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

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• 10381780064381 - B-BOP: 2024-07-11 In case of severe deformities of the forefoot, the basal osteotomy may be preferable to the distal osteotomy as it promotes a gr
• M248119580ND1 - I.CO.S®: 2024-04-03 The trephine, with a 6.0mm diameter tri shank attachment, is used to core the cortical bone around the 4.0mm compression screw h
• M248119590ND1 - I.CO.S®: 2024-04-03 The trephine, with a 6.0mm diameter tri shank attachment, is used to core the cortical bone around the 6.5mm compression screw h
• M248139107ND1 - METIS®: 2024-02-07 The metatarsal osteotome is used to cut the bone after the pre-cutting stage with the cutting guide, for the insertion of the im
• M248529061ND1 - SURFIX®: 2023-09-18 This K-Wire of diameter 2.5 mm and of length 250 mm is used to guide the instrumentation and the screws.
• 10381780043317 - BASAL DORSAL PLATE: 2023-09-18 The Newdeal sterile Basal Dorsal Plate consists of an osteosynthesis plate designed to bridge the tarsometatarsal joints. It is