HemiCAPDF® 9M52-1545-W

GUDID M5289M521545W0

15mm Articular Comp,TOE2, 1.5mm x 4.5mm MTP CE

ARTHROSURFACE INCORPORATED

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: M5289M521545W0
• NIH Device Record Key: d70ed03a-367a-419d-8e0b-e7657cb60d51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HemiCAPDF®
• Version Model Number: 9M52-1545-W
• Catalog Number: 9M52-1545-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: 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: 508-520-3003
• Email: contact@arthrosurface.com
• Phone: 508-520-3003
• Email: contact@arthrosurface.com
• Phone: 508-520-3003
• Email: contact@arthrosurface.com
• Phone: 508-520-3003
• Email: contact@arthrosurface.com
• Phone: 508-520-3003
• Email: contact@arthrosurface.com
• Phone: 508-520-3003
• Email: contact@arthrosurface.com
• Phone: 508-520-3003
• Email: contact@arthrosurface.com
• Phone: 508-520-3003
• Email: contact@arthrosurface.com
• Phone: 508-520-3003
• Email: contact@arthrosurface.com
• Phone: 508-520-3003
• Email: contact@arthrosurface.com
• Phone: 508-520-3003
• Email: contact@arthrosurface.com
• Phone: 508-520-3003
• Email: contact@arthrosurface.com
• Phone: 508-520-3003
• Email: contact@arthrosurface.com
• Phone: 508-520-3003
• Email: contact@arthrosurface.com
• Phone: 508-520-3003
• Email: contact@arthrosurface.com
• Phone: 508-520-3003
• Email: contact@arthrosurface.com

Device Dimensions

• Outer Diameter: 15 Millimeter
• Outer Diameter: 15 Millimeter
• Outer Diameter: 15 Millimeter
• Outer Diameter: 15 Millimeter
• Outer Diameter: 15 Millimeter
• Outer Diameter: 15 Millimeter
• Outer Diameter: 15 Millimeter
• Outer Diameter: 15 Millimeter
• Outer Diameter: 15 Millimeter
• Outer Diameter: 15 Millimeter
• Outer Diameter: 15 Millimeter
• Outer Diameter: 15 Millimeter
• Outer Diameter: 15 Millimeter
• Outer Diameter: 15 Millimeter
• Outer Diameter: 15 Millimeter
• Outer Diameter: 15 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M5289M521545W0 [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: 2015-09-15

On-Brand Devices [HemiCAPDF®]

• M5289M522545W0: 15mm Articular Comp,TOE2, 2.5mm x 4.5mm CE
• M5289M522545A0: 15mm Articular Comp,TOE2, 2.5mm x 4.5mm
• M5289M522535W0: 15mm Articular Comp,TOE2, 2.5mm x 3.5mm MTP CE
• M5289M522535A0: 15mm Articular Comp,TOE2, 2.5mm x 3.5mm MTP
• M5289M521545W0: 15mm Articular Comp,TOE2, 1.5mm x 4.5mm MTP CE
• M5289M521545A0: 15mm Articular Comp,TOE2, 1.5mm x 4.5mm MTP
• M5289M521535W0: 15mm Articular Comp,TOE2, 1.5mm x 3.5mm MTP CE
• M5289M521535A0: 15mm Articular Comp,TOE2, 1.5mm x 3.5mm MTP