HemiCAP® 9122-2025-W

GUDID M52891222025W0

12mm Art Comp 2.0mm x 2.5mm, MTP CE

ARTHROSURFACE INCORPORATED

Partial metatarsophalangeal joint prosthesis
Primary Device IDM52891222025W0
NIH Device Record Keyba8d9f93-1ad3-43a1-9de6-c463514f1b41
Commercial Distribution StatusIn Commercial Distribution
Brand NameHemiCAP®
Version Model Number9122-2025-W
Catalog Number9122-2025-W
Company DUNS144666109
Company NameARTHROSURFACE INCORPORATED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone508-520-3003
Emailcontact@arthrosurface.com
Phone508-520-3003
Emailcontact@arthrosurface.com
Phone508-520-3003
Emailcontact@arthrosurface.com
Phone508-520-3003
Emailcontact@arthrosurface.com
Phone508-520-3003
Emailcontact@arthrosurface.com
Phone508-520-3003
Emailcontact@arthrosurface.com
Phone508-520-3003
Emailcontact@arthrosurface.com
Phone508-520-3003
Emailcontact@arthrosurface.com
Phone508-520-3003
Emailcontact@arthrosurface.com
Phone508-520-3003
Emailcontact@arthrosurface.com
Phone508-520-3003
Emailcontact@arthrosurface.com
Phone508-520-3003
Emailcontact@arthrosurface.com
Phone508-520-3003
Emailcontact@arthrosurface.com
Phone508-520-3003
Emailcontact@arthrosurface.com
Phone508-520-3003
Emailcontact@arthrosurface.com
Phone508-520-3003
Emailcontact@arthrosurface.com

Device Dimensions

Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM52891222025W0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWDProsthesis, Toe, Hemi-, Phalangeal

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-02-21
Device Publish Date2015-09-15

On-Brand Devices [HemiCAP®]

M528800040100DISPOSABLE REAMER, 40MM
M52891522545W015mm Articular Comp 2.5mm x 4.5mm MTP CE
M52891522545A015mm Articular Comp 2.5mm x 4.5mm MTP
M52891522535W015mm Articular Comp 2.5mm x 3.5mm MTP CE
M52891522535A015mm Articular Comp 2.5mm x 3.5mm MTP
M52891522040W015mm Articular Comp 2.0mm x 4.0mm MTP CE
M52891522040A015mm Articular Comp 2.0mm x 4.0mm MTP
M52891522030W015mm Articular Comp 2.0mm x 3.0mm MTP CE
M52891522030A015mm Articular Comp 2.0mm x 3.0mm MTP
M52891521535W015mm Articular Comp 1.5mm x 3.5mm MTP CE
M52891521535A015mm Articular Comp 1.5mm x 3.5mm MTP
M52891521525W015mm Articular Comp 1.5mm x 2.5mm MTP CE
M52891521525A015mm Articular Comp 1.5mm x 2.5mm MTP
M52891222030W012mm Art Comp 2.0mm x 3.0mm, MTP CE
M52891222030A012mm Art Comp 2.0mm x 3.0mm, MTP
M52891222025W012mm Art Comp 2.0mm x 2.5mm, MTP CE
M52891222025A012mm Art Comp 2.0mm x 2.5mm, MTP
M52891221525W012mm Art Comp 1.5mm x 2.5mm, MTP CE
M52891221525A012mm Art Comp 1.5mm x 2.5mm, MTP
M52891221520W012mm Art Comp 1.5mm x 2.0mm, MTP CE
M52891221520A012mm Art Comp 1.5mm x 2.0mm, MTP
M52891221020W012mm Art Comp 1.0mm x 2.0mm, MTP CE
M52891221020A012mm Art Comp 1.0mm x 2.0mm, MTP
M52891221015W012mm Art Comp 1.0mm x 1.5mm, MTP CE
M52891221015A012mm Art Comp 1.0mm x 1.5mm, MTP
M52890950018W09.5mm x 18mm, Taper Post, MTP CE
M52890950018A09.5mm x 18mm, Taper Post, MTP
M52890800016W08.0mm x 16mm, Taper Post, MTP CE
M52890800016A08.0mm x 16mm, Taper Post, MTP
M52890700013W0Taper Post, 7.0mm Dia X 13mm Lg, MTP CE

Trademark Results [HemiCAP]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HEMICAP
HEMICAP
78225563 3039890 Live/Registered
ARTHROSURFACE INCORPORATED
2003-03-14

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.