HALLU-FIX 117350ND

GUDID 10381780043515

The non sterile HALLU-C plates are available in different sizes (left/right). They are both low profile titanium alloy plates dedicated to the first metatarso-phalangeal arthrodesis. Those implants are pre-bent for optimal anatomical adaptation. A dorsal flexion bending adjustment is possible for the HALLU-C plates. They are implanted using SNAP-OFF screws which exist in different diameters and sizes.

NEWDEAL

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 10381780043515
• NIH Device Record Key: da5281aa-298f-4948-8b7f-cb7e0ca4202d
• Commercial Distribution Discontinuation: 2027-12-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HALLU-FIX
• Version Model Number: 117350ND
• Catalog Number: 117350ND
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780043515 [Primary]
HIBCC	M248117350ND1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021626

FDA Product Code

• HRS: PLATE, FIXATION, BONE

Sterilization

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

[10381780043515]

Moist Heat or Steam Sterilization

[10381780043515]

Moist Heat or Steam Sterilization

[10381780043515]

Moist Heat or Steam Sterilization

[10381780043515]

Moist Heat or Steam Sterilization

[10381780043515]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2023-02-09
• Device Publish Date: 2017-10-09

On-Brand Devices [HALLU-FIX]

• 10381780064404: The Hallu-Fix set includes Hallu-Fix S Plates, Hallu-Fix C Plates, screws, and instruments. The
• 10381780043584: The sterile HALLU-C plates are available in different sizes (left/right). They are both low prof
• 10381780043577: The non sterile HALLU-C plates are available in different sizes (left/right). They are both low
• 10381780043560: The sterile HALLU-C plates are available in different sizes (left/right). They are both low prof
• 10381780043553: The non sterile HALLU-C plates are available in different sizes (left/right). They are both low
• 10381780043546: The sterile HALLU-C plates are available in different sizes (left/right). They are both low prof
• 10381780043539: The non sterile HALLU-C plates are available in different sizes (left/right). They are both low
• 10381780043522: The sterile HALLU-C plates are available in different sizes (left/right). They are both low prof
• 10381780043515: The non sterile HALLU-C plates are available in different sizes (left/right). They are both low
• 10381780043508: The sterile HALLU-C plates are available in different sizes (left/right). They are both low prof
• 10381780043492: The non sterile HALLU-C plates are available in different sizes (left/right). They are both low
• 10381780043485: The sterile HALLU-C plates are available in different sizes (left/right). They are both low prof
• 10381780043478: The non sterile HALLU-C plates are available in different sizes (left/right). They are both low
• 10381780043461: The sterile HALLU-S plates are available in different sizes (left/right). They are both low prof
• 10381780043454: The non sterile HALLU-S plates are available in different sizes (left/right). They are both low
• 10381780043447: The sterile HALLU-S plates are available in different sizes (left/right). They are both low prof
• 10381780043430: The non sterile HALLU-S plates are available in different sizes (left/right). They are both low
• 10381780043423: The sterile HALLU-S plates are available in different sizes (left/right). They are both low prof
• 10381780043416: The non sterile HALLU-S plates are available in different sizes (left/right). They are both low
• 10381780043409: The sterile HALLU-S plates are available in different sizes (left/right). They are both low prof
• 10381780043393: The non sterile HALLU-S plates are available in different sizes (left/right). They are both low
• 10381780043386: The sterile HALLU-S plates are available in different sizes (left/right). They are both low prof
• 10381780043379: The non sterile HALLU-S plates are available in different sizes (left/right). They are both low
• 10381780043362: The sterile HALLU-S plates are available in different sizes (left/right). They are both low prof
• 10381780043355: The non sterile HALLU-S plates are available in different sizes (left/right). They are both low