DynaFORCE™ HiMax 7118-2020

GUDID 00815432023554

DynaFORCE is a Nitinol Superelastic bone staple for use in surgery of the hand and foot for bone fragment osteotomy fixation and joint arthrodesis

CROSSROADS EXTREMITY SYSTEMS

Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable

• Primary Device ID: 00815432023554
• NIH Device Record Key: 1c2bd65d-f4d6-4df0-97d9-65d5b47a9f81
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DynaFORCE™ HiMax
• Version Model Number: 7118-2020
• Catalog Number: 7118-2020
• Company DUNS: 058864308
• Company Name: CROSSROADS EXTREMITY SYSTEMS
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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: 901-221-8406
• Email: info@crextremity.com
• Phone: 901-221-8406
• Email: info@crextremity.com
• Phone: 901-221-8406
• Email: info@crextremity.com
• Phone: 901-221-8406
• Email: info@crextremity.com
• Phone: 901-221-8406
• Email: info@crextremity.com
• Phone: 901-221-8406
• Email: info@crextremity.com
• Phone: 901-221-8406
• Email: info@crextremity.com
• Phone: 901-221-8406
• Email: info@crextremity.com
• Phone: 901-221-8406
• Email: info@crextremity.com
• Phone: 901-221-8406
• Email: info@crextremity.com
• Phone: 901-221-8406
• Email: info@crextremity.com
• Phone: 901-221-8406
• Email: info@crextremity.com
• Phone: 901-221-8406
• Email: info@crextremity.com
• Phone: 901-221-8406
• Email: info@crextremity.com
• Phone: 901-221-8406
• Email: info@crextremity.com
• Phone: 901-221-8406
• Email: info@crextremity.com
• Phone: 901-221-8406
• Email: info@crextremity.com
• Phone: 901-221-8406
• Email: info@crextremity.com
• Phone: 901-221-8406
• Email: info@crextremity.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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00815432023554 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142727

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-04-04

On-Brand Devices [DynaFORCE™ HiMax]

• 00815432023585: DynaFORCE is a Nitinol Superelastic bone staple for use in surgery of the hand and foot for bone
• 00815432023578: DynaFORCE is a Nitinol Superelastic bone staple for use in surgery of the hand and foot for bone
• 00815432023561: DynaFORCE is a Nitinol Superelastic bone staple for use in surgery of the hand and foot for bone
• 00815432023554: DynaFORCE is a Nitinol Superelastic bone staple for use in surgery of the hand and foot for bone
• 00815432023547: DynaFORCE is a Nitinol Superelastic bone staple for use in surgery of the hand and foot for bone
• 00815432023530: DynaFORCE is a Nitinol Superelastic bone staple for use in surgery of the hand and foot for bone
• 00815432023523: DynaFORCE is a Nitinol Superelastic bone staple for use in surgery of the hand and foot for bone
• 00815432023516: DynaFORCE is a Nitinol Superelastic bone staple for use in surgery of the hand and foot for bone
• 00815432023509: DynaFORCE is a Nitinol Superelastic bone staple for use in surgery of the hand and foot for bone
• 00815432028177: DynaFORCE is a Nitinol Superelastic bone staple for use in surgery of the hand and foot for bone
• 00815432028160: DynaFORCE is a Nitinol Superelastic bone staple for use in surgery of the hand and foot for bone
• 00815432028153: DynaFORCE is a Nitinol Superelastic bone staple for use in surgery of the hand and foot for bone
• 00815432028146: DynaFORCE is a Nitinol Superelastic bone staple for use in surgery of the hand and foot for bone
• 00815432028139: DynaFORCE is a Nitinol Superelastic bone staple for use in surgery of the hand and foot for bone
• 00815432028122: DynaFORCE is a Nitinol Superelastic bone staple for use in surgery of the hand and foot for bone
• 00815432028115: DynaFORCE is a Nitinol Superelastic bone staple for use in surgery of the hand and foot for bone
• 00815432027286: DynaFORCE is a Nitinol Superelastic bone staple for use in surgery of the hand and foot for bone
• 00815432027279: DynaFORCE is a Nitinol Superelastic bone staple for use in surgery of the hand and foot for bone