MBA™ Titanium Subtalar Implant System 050109

GUDID M2480501091

The MBA titanium subtalar implant is cylindrical in shape and incorporates a center cannula designed for use with a guide wire to facilitate proper placement of the implant. The implants are indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint.

INTEGRA LIFESCIENCES CORPORATION

Subtalar implant, non-bioabsorbable, sterile

• Primary Device ID: M2480501091
• NIH Device Record Key: f207df12-3cac-4a6b-895f-fb2ddee769fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MBA™ Titanium Subtalar Implant System
• Version Model Number: 050109
• Catalog Number: 050109
• Company DUNS: 963856096
• Company Name: INTEGRA LIFESCIENCES CORPORATION
• 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: false
• 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
• 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

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Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780065517 [Primary]
HIBCC	M2480501091 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K960692

FDA Product Code

• HWC: Screw, 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: 4
• Public Version Date: 2021-02-26
• Device Publish Date: 2017-10-09

On-Brand Devices [MBA™ Titanium Subtalar Implant System]

• M2480510021: MBA™ Titanium Subtalar Implant System PROBE
• M2480550011: MBA TRAY
• M2480501121: The MBA titanium subtalar implant is cylindrical in shape and incorporates a center cannula desi
• M2480501101: The MBA titanium subtalar implant is cylindrical in shape and incorporates a center cannula desi
• M2480501091: The MBA titanium subtalar implant is cylindrical in shape and incorporates a center cannula desi
• M2480501081: The MBA titanium subtalar implant is cylindrical in shape and incorporates a center cannula desi
• M2480501061: The MBA titanium subtalar implant is cylindrical in shape and incorporates a center cannula desi