HemiCAPDF® 9M52-2535-W

GUDID M5289M522535W0

15mm Articular Comp,TOE2, 2.5mm x 3.5mm MTP CE

ARTHROSURFACE INCORPORATED

Partial metatarsophalangeal joint prosthesis
Primary Device IDM5289M522535W0
NIH Device Record Key6d1b8cd5-9082-4114-bf8e-7d78c7efbdb0
Commercial Distribution StatusIn Commercial Distribution
Brand NameHemiCAPDF®
Version Model Number9M52-2535-W
Catalog Number9M52-2535-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 Diameter15 Millimeter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM5289M522535W0 [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 [HemiCAPDF®]

M5289M522545W015mm Articular Comp,TOE2, 2.5mm x 4.5mm CE
M5289M522545A015mm Articular Comp,TOE2, 2.5mm x 4.5mm
M5289M522535W015mm Articular Comp,TOE2, 2.5mm x 3.5mm MTP CE
M5289M522535A015mm Articular Comp,TOE2, 2.5mm x 3.5mm MTP
M5289M521545W015mm Articular Comp,TOE2, 1.5mm x 4.5mm MTP CE
M5289M521545A015mm Articular Comp,TOE2, 1.5mm x 4.5mm MTP
M5289M521535W015mm Articular Comp,TOE2, 1.5mm x 3.5mm MTP CE
M5289M521535A015mm Articular Comp,TOE2, 1.5mm x 3.5mm MTP

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