K2™

GUDID M248HEMISET1

K2™ Hemi Instrument Set (20-6000)

Ascension Orthopedics, Inc.

Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis

• Primary Device ID: M248HEMISET1
• NIH Device Record Key: 1553a8dc-bb4f-46be-918e-0f057f5bfa84
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: K2™
• Version Model Number: HEMISET
• Company DUNS: 942377524
• Company Name: Ascension Orthopedics, Inc.
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780257240 [Primary]
HIBCC	M248HEMISET1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023770

FDA Product Code

• KWD: PROSTHESIS, TOE, HEMI-, PHALANGEAL

Sterilization

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

[M248HEMISET1]

Moist Heat or Steam Sterilization

[M248HEMISET1]

Moist Heat or Steam Sterilization

[M248HEMISET1]

Moist Heat or Steam Sterilization

[M248HEMISET1]

Moist Heat or Steam Sterilization

[M248HEMISET1]

Moist Heat or Steam Sterilization

[M248HEMISET1]

Moist Heat or Steam Sterilization

[M248HEMISET1]

Moist Heat or Steam Sterilization

[M248HEMISET1]

Moist Heat or Steam Sterilization

[M248HEMISET1]

Moist Heat or Steam Sterilization

[M248HEMISET1]

Moist Heat or Steam Sterilization

[M248HEMISET1]

Moist Heat or Steam Sterilization

[M248HEMISET1]

Moist Heat or Steam Sterilization

[M248HEMISET1]

Moist Heat or Steam Sterilization

[M248HEMISET1]

Moist Heat or Steam Sterilization

[M248HEMISET1]

Moist Heat or Steam Sterilization

[M248HEMISET1]

Moist Heat or Steam Sterilization

[M248HEMISET1]

Moist Heat or Steam Sterilization

[M248HEMISET1]

Moist Heat or Steam Sterilization

[M248HEMISET1]

Moist Heat or Steam Sterilization

[M248HEMISET1]

Moist Heat or Steam Sterilization

[M248HEMISET1]

Moist Heat or Steam Sterilization

[M248HEMISET1]

Moist Heat or Steam Sterilization

[M248HEMISET1]

Moist Heat or Steam Sterilization

[M248HEMISET1]

Moist Heat or Steam Sterilization

[M248HEMISET1]

Moist Heat or Steam Sterilization

[M248HEMISET1]

Moist Heat or Steam Sterilization

[M248HEMISET1]

Moist Heat or Steam Sterilization

[M248HEMISET1]

Moist Heat or Steam Sterilization

[M248HEMISET1]

Moist Heat or Steam Sterilization

[M248HEMISET1]

Moist Heat or Steam Sterilization

[M248HEMISET1]

Moist Heat or Steam Sterilization

[M248HEMISET1]

Moist Heat or Steam Sterilization

[M248HEMISET1]

Moist Heat or Steam Sterilization

[M248HEMISET1]

Moist Heat or Steam Sterilization

[M248HEMISET1]

Moist Heat or Steam Sterilization

[M248HEMISET1]

Moist Heat or Steam Sterilization

[M248HEMISET1]

Moist Heat or Steam Sterilization

[M248HEMISET1]

Moist Heat or Steam Sterilization

[M248HEMISET1]

Moist Heat or Steam Sterilization

[M248HEMISET1]

Moist Heat or Steam Sterilization

[M248HEMISET1]

Moist Heat or Steam Sterilization

[M248HEMISET1]

Moist Heat or Steam Sterilization

[M248HEMISET1]

Moist Heat or Steam Sterilization

[M248HEMISET1]

Moist Heat or Steam Sterilization

[M248HEMISET1]

Moist Heat or Steam Sterilization

[M248HEMISET1]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-03-04
• Device Publish Date: 2016-07-25

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• 10381780123057 - CAPTURE™ High Torque Screw System: 2023-09-18 The washer is used in conjunction with the Capture High Torque Screw System.
• 10381780123064 - CAPTURE™ High Torque Screw System: 2023-09-18 The washer is used in conjunction with the Capture High Torque Screw System.
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