HALLU LOCK 290335SND

GUDID 10381780044147

The sterile HALLU Lock plates are available in two different designs (the HALLU Lock S plate and the HALLU Lock C plate) and in different sizes (left/right). They are implanted using Newdeal fixed or variable angle locking system fixation screws and washers. They are both low profile Titanium plates dedicated to the first metatarso-phalangeal arthrodesis. Pre-bending is possible to completely fit the anatomical shape of the joint.

NEWDEAL

Orthopaedic fixation plate, non-bioabsorbable, sterile

• Primary Device ID: 10381780044147
• NIH Device Record Key: 9681c589-ea84-42a1-aec1-468f73d47194
• Commercial Distribution Discontinuation: 2027-12-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HALLU LOCK
• Version Model Number: 290335SND
• Catalog Number: 290335SND
• 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: true
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• 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
• 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
• 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
• 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
• 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.
• 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	10381780044147 [Primary]
HIBCC	M248290335SND1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083154

FDA Product Code

• HRS: PLATE, FIXATION, BONE

Sterilization

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

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 LOCK]

• M248290660SND1: The sterile HALLU Lock plates are available in two different designs (the HALLU Lock S plate and
• M248290655SND1: The sterile HALLU Lock plates are available in two different designs (the HALLU Lock S plate and
• 10381780044277: The sterile HALLU Lock plates are available in two different designs (the HALLU Lock S plate and
• M248290645SND1: The sterile HALLU Lock plates are available in two different designs (the HALLU Lock S plate and
• 10381780044253: The sterile HALLU Lock plates are available in two different designs (the HALLU Lock S plate and
• M248290555SND1: The sterile HALLU Lock plates are available in two different designs (the HALLU Lock S plate and
• 10381780044239: The sterile HALLU Lock plates are available in two different designs (the HALLU Lock S plate and
• M248290545SND1: The sterile HALLU Lock plates are available in two different designs (the HALLU Lock S plate and
• 10381780044215: The sterile HALLU Lock plates are available in two different designs (the HALLU Lock S plate and
• M248290445SND1: The sterile HALLU Lock plates are available in two different designs (the HALLU Lock S plate and
• 10381780044192: The sterile HALLU Lock plates are available in two different designs (the HALLU Lock S plate and
• M248290435SND1: The sterile HALLU Lock plates are available in two different designs (the HALLU Lock S plate and
• 10381780044178: The sterile HALLU Lock plates are available in two different designs (the HALLU Lock S plate and
• M248290345SND1: The sterile HALLU Lock plates are available in two different designs (the HALLU Lock S plate and
• 10381780044154: The sterile HALLU Lock plates are available in two different designs (the HALLU Lock S plate and
• 10381780044147: The sterile HALLU Lock plates are available in two different designs (the HALLU Lock S plate and
• 10381780044130: The sterile HALLU Lock plates are available in two different designs (the HALLU Lock S plate and
• M248290255SND1: The sterile HALLU Lock plates are available in two different designs (the HALLU Lock S plate and
• 10381780044116: The sterile HALLU Lock plates are available in two different designs (the HALLU Lock S plate and
• 10381780044109: The sterile HALLU Lock plates are available in two different designs (the HALLU Lock S plate and
• 10381780044093: The sterile HALLU Lock plates are available in two different designs (the HALLU Lock S plate and
• 10381780044086: The sterile HALLU Lock plates are available in two different designs (the HALLU Lock S plate and
• 10381780044079: The sterile HALLU Lock plates are available in two different designs (the HALLU Lock S plate and
• 10381780044062: The sterile HALLU Lock plates are available in two different designs (the HALLU Lock S plate and