TIBIAXYS 150010ND

GUDID 10381780043690

The Newdeal TIBIAXYS System consists of bone plates and screws for arthrodesis, osteotomies and fractures of ankle joint, distal tibia and fibula. They are implanted using Newdeal locking system fixation screws and washers. This system includes as many fixation screws and washers as threaded lipped sockets on the plate. All plates and screws are manufactured from titanium alloy. The left medial anterior tibial plate is delivered non sterile.

NEWDEAL

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 10381780043690
• NIH Device Record Key: 489bd006-3083-4b3e-b464-aca71b3a7fb1
• Commercial Distribution Discontinuation: 2027-12-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TIBIAXYS
• Version Model Number: 150010ND
• Catalog Number: 150010ND
• 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	10381780043690 [Primary]
HIBCC	M248150010ND1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073375

FDA Product Code

• HRS: PLATE, FIXATION, BONE

Sterilization

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

[10381780043690]

Moist Heat or Steam Sterilization

[10381780043690]

Moist Heat or Steam Sterilization

[10381780043690]

Moist Heat or Steam Sterilization

[10381780043690]

Moist Heat or Steam Sterilization

[10381780043690]

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 [TIBIAXYS]

• 10381780064466: The TIBIAXYS System consists of bone plates and screws for arthrodesis, osteotomies and fracture
• 10381780048350: The 4mm diameter TIBIAXYS cortical screw used only on TIBIAXYS anterior plates for ankle arthrod
• 10381780048343: The 4mm diameter TIBIAXYS cortical screw used only on TIBIAXYS anterior plates for ankle arthrod
• 10381780048336: The 4mm diameter TIBIAXYS cortical screw used only on TIBIAXYS anterior plates for ankle arthrod
• 10381780048329: The 4mm diameter TIBIAXYS cortical screw used only on TIBIAXYS anterior plates for ankle arthrod
• 10381780048312: The 4mm diameter TIBIAXYS cortical screw used only on TIBIAXYS anterior plates for ankle arthrod
• 10381780048305: The 4mm diameter TIBIAXYS cortical screw used only on TIBIAXYS anterior plates for ankle arthrod
• 10381780048299: The 4mm diameter TIBIAXYS cortical screw used only on TIBIAXYS anterior plates for ankle arthrod
• 10381780048282: The 4mm diameter TIBIAXYS cortical screw used only on TIBIAXYS anterior plates for ankle arthrod
• 10381780048275: The 4mm diameter TIBIAXYS cortical screw used only on TIBIAXYS anterior plates for ankle arthrod
• 10381780048268: The 4mm diameter TIBIAXYS cortical screw used only on TIBIAXYS anterior plates for ankle arthrod
• 10381780048251: The 4mm diameter TIBIAXYS cortical screw used only on TIBIAXYS anterior plates for ankle arthrod
• 10381780048244: The 4mm diameter TIBIAXYS cortical screw used only on TIBIAXYS anterior plates for ankle arthrod
• 10381780048237: The 4mm diameter TIBIAXYS cortical screw used only on TIBIAXYS anterior plates for ankle arthrod
• 10381780043843: The Newdeal TIBIAXYS System consists of bone plates and screws for arthrodesis, osteotomies and
• 10381780043836: The Newdeal TIBIAXYS System consists of bone plates and screws for arthrodesis, osteotomies and
• 10381780043829: The Newdeal TIBIAXYS System consists of bone plates and screws for arthrodesis, osteotomies and
• 10381780043805: The Newdeal TIBIAXYS System consists of bone plates and screws for arthrodesis, osteotomies and
• 10381780043782: The Newdeal TIBIAXYS System consists of bone plates and screws for arthrodesis, osteotomies and
• 10381780043768: The Newdeal TIBIAXYS System consists of bone plates and screws for arthrodesis, osteotomies and
• 10381780043744: The Newdeal TIBIAXYS System consists of bone plates and screws for arthrodesis, osteotomies and
• 10381780043720: The Newdeal TIBIAXYS System consists of bone plates and screws for arthrodesis, osteotomies and
• 10381780043706: The Newdeal TIBIAXYS System consists of bone plates and screws for arthrodesis, osteotomies and
• 10381780043690: The Newdeal TIBIAXYS System consists of bone plates and screws for arthrodesis, osteotomies and