bioBLOCK® Subtalar Implant System 040009

GUDID M2480400090

The bioBLOCK Subtalar Implant consists of a soft-threaded implant, designed to be inserted between the posterior and middle facets of the subtalar joint, trial implant and the corresponding instrumentation to facilitate insertion. The implant is cylindrical in shape and incorporates a center cannula designed for use with a guide wire to facilitate proper placement. The implant is indicated as an internal support in the treatment of flat foot, providing structural support.

INTEGRA LIFESCIENCES CORPORATION

Subtalar implant, non-bioabsorbable, sterile

• Primary Device ID: M2480400090
• NIH Device Record Key: e2277bf3-342f-432b-99af-8951f16887be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: bioBLOCK® Subtalar Implant System
• Version Model Number: 040009
• Catalog Number: 040009
• 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

Device Dimensions

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Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780066569 [Primary]
HIBCC	M2480400090 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051611

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 [bioBLOCK® Subtalar Implant System]

• M2480400120: The bioBLOCK Subtalar Implant consists of a soft-threaded implant, designed to be inserted betwe
• M2480400110: The bioBLOCK Subtalar Implant consists of a soft-threaded implant, designed to be inserted betwe
• M2480400100: The bioBLOCK Subtalar Implant consists of a soft-threaded implant, designed to be inserted betwe
• M2480400090: The bioBLOCK Subtalar Implant consists of a soft-threaded implant, designed to be inserted betwe
• M2480400080: The bioBLOCK Subtalar Implant consists of a soft-threaded implant, designed to be inserted betwe