Incompass Total Ankle System 3385118M

GUDID 00889797114110

Tibial Stem

WRIGHT MEDICAL TECHNOLOGY, INC.

Fixed-bearing total ankle prosthesis
Primary Device ID00889797114110
NIH Device Record Key054089d5-9f66-4891-80b5-ea5c4f92607b
Commercial Distribution StatusIn Commercial Distribution
Brand NameIncompass Total Ankle System
Version Model Number3385118M
Catalog Number3385118M
Company DUNS807201207
Company NameWRIGHT MEDICAL TECHNOLOGY, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com

Device Dimensions

Outer Diameter18 Millimeter
Device Size Text, specify0
Outer Diameter18 Millimeter
Device Size Text, specify0
Outer Diameter18 Millimeter
Device Size Text, specify0
Outer Diameter18 Millimeter
Device Size Text, specify0
Outer Diameter18 Millimeter
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100889797114110 [Primary]

FDA Product Code

HSNPROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-22
Device Publish Date2025-08-14

On-Brand Devices [Incompass Total Ankle System]

00889797114257Tibial Stem
00889797114240Tibial Stem
00889797114233Tibial Stem
00889797114226Tibial Stem
00889797114219Tibial Stem
00889797114202Tibial Stem
00889797114110Tibial Stem
00889797114103Tibial Stem
00889797114097Tibial Stem
00889797114080Tibial Stem
00889797114073Tibial Stem
00889797114066Tibial Stem
00889797114059Tibial Stem
00889797114042Tibial Stem
00889797114035Tibial Stem
00889797113861Tibial Stem
00889797113854Tibial Stem
00889797113847Tibial Stem
00889797113830Tibial Stem
00889797113823Tibial Stem
00889797113816Tibial Stem
00889797113809Tibial Stem
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