Incompass Total Ankle System 33820067

GUDID 00889797111478

Depth Gauge Proximal Tibia Cut

WRIGHT MEDICAL TECHNOLOGY, INC.

Orthopaedic bone pin, non-bioabsorbable
Primary Device ID00889797111478
NIH Device Record Key6796048f-1b0e-4c90-a951-0d809842b753
Commercial Distribution StatusIn Commercial Distribution
Brand NameIncompass Total Ankle System
Version Model Number33820067
Catalog Number33820067
Company DUNS807201207
Company NameWRIGHT MEDICAL TECHNOLOGY, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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
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
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 Identifiers

Device Issuing AgencyDevice ID
GS100889797111478 [Primary]

FDA Product Code

HTJGAUGE, DEPTH

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00889797111478]

Moist Heat or Steam Sterilization


[00889797111478]

Moist Heat or Steam Sterilization


[00889797111478]

Moist Heat or Steam Sterilization


[00889797111478]

Moist Heat or Steam Sterilization


[00889797111478]

Moist Heat or Steam Sterilization


[00889797111478]

Moist Heat or Steam Sterilization


[00889797111478]

Moist Heat or Steam Sterilization


[00889797111478]

Moist Heat or Steam Sterilization


[00889797111478]

Moist Heat or Steam Sterilization


[00889797111478]

Moist Heat or Steam Sterilization


[00889797111478]

Moist Heat or Steam Sterilization


[00889797111478]

Moist Heat or Steam Sterilization


[00889797111478]

Moist Heat or Steam Sterilization


[00889797111478]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-08
Device Publish Date2025-08-29

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
00889797114813Poly
00889797114806Poly
00889797114790Poly
00889797114783Poly
00889797114776Poly
00889797114769Poly
00889797114752Poly
00889797114745Poly
00889797114738Poly
00889797114721Poly
00889797114714Poly
00889797114707Poly
00889797114691Poly
00889797114684Poly
00889797114677Poly
00889797114660Poly
00889797114653Poly
00889797114646Poly
00889797114639Poly
00889797114622Poly
00889797114615Poly
00889797114608Poly
00889797114592Poly
00889797114585Poly
00889797114578Poly
00889797114561Poly
00889797114554Poly
00889797114547Poly

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.