HemiCAPDF-P® 9P15-PB02-W

GUDID M5289P15PB02W0

Modular Insert, 1.5mm Offset-02(4.6mm Thick)

ARTHROSURFACE INCORPORATED

Partial metatarsophalangeal joint prosthesis

• Primary Device ID: M5289P15PB02W0
• NIH Device Record Key: 12bfadb1-f2f0-4f5e-a2c0-eacbc9848289
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HemiCAPDF-P®
• Version Model Number: 9P15-PB02-W
• Catalog Number: 9P15-PB02-W
• Company DUNS: 144666109
• Company Name: ARTHROSURFACE INCORPORATED
• 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: 508-520-3003
• Email: gbutterfield@arthrosurface.com
• Phone: 508-520-3003
• Email: gbutterfield@arthrosurface.com
• Phone: 508-520-3003
• Email: gbutterfield@arthrosurface.com
• Phone: 508-520-3003
• Email: gbutterfield@arthrosurface.com
• Phone: 508-520-3003
• Email: gbutterfield@arthrosurface.com
• Phone: 508-520-3003
• Email: gbutterfield@arthrosurface.com
• Phone: 508-520-3003
• Email: gbutterfield@arthrosurface.com
• Phone: 508-520-3003
• Email: gbutterfield@arthrosurface.com
• Phone: 508-520-3003
• Email: gbutterfield@arthrosurface.com
• Phone: 508-520-3003
• Email: gbutterfield@arthrosurface.com
• Phone: 508-520-3003
• Email: gbutterfield@arthrosurface.com
• Phone: 508-520-3003
• Email: gbutterfield@arthrosurface.com
• Phone: 508-520-3003
• Email: gbutterfield@arthrosurface.com
• Phone: 508-520-3003
• Email: gbutterfield@arthrosurface.com
• Phone: 508-520-3003
• Email: gbutterfield@arthrosurface.com
• Phone: 508-520-3003
• Email: gbutterfield@arthrosurface.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M5289P15PB02W0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131377

FDA Product Code

• KWD: Prosthesis, Toe, Hemi-, Phalangeal

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: 2022-02-21
• Device Publish Date: 2016-07-14

On-Brand Devices [HemiCAPDF-P®]

• M5289P15S180W0: Fixation Component , DF-P
• M5289P15PB02W0: Modular Insert, 1.5mm Offset-02(4.6mm Thick)
• M5289P15PB01W0: Modular Insert, 1.5mm Offset-01(3.6mm Thick)
• M5289P15PA02W0: Modular Insert, 1.5mm Offset-02(4.6mm Thick)
• M5289F15PA01W0: Modular Insert, 1.5mm Offset-01(3.6mm Thick)