FDA.report

Incompass Total Ankle System

Primary DI
00889797112758
Brand
Incompass Total Ankle System
Company
WRIGHT MEDICAL TECHNOLOGY, INC.
Model
33820138
Catalog number
33820138
Device description
Talar Peg Drill
Published
2025-08-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GFGBIT, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
GFGBit, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00889797112758PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00889797112758008897971127588897971127580889797112758

GMDN Terms

TermDefinition
Bone-resection orthopaedic reamer, reusableAn orthopaedic surgical instrument intended to resect bone (cut out part of the bone), and in some cases hypertrophic tissue [e.g., ligamentum flavum], to: 1) accept a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna); and/or 2) relieve pressure at or facilitate access to a joint. Commonly called a mill or a reamer, it is typically designed as a stainless steel cylindrical body with an end/circumferential cutting edge and is attached to a shaft for manual or powered rotation. This is a reusable device.

Device Sizes

TypeValueUnit
Outer Diameter3.8Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)238-7117customerservice@wmt.com

Regulatory Flags

DUNS number
807201207
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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00889797023337INVISION600021002016-09-17
00889797023344INVISION600021012016-09-17
00889797023351INVISION600022002016-09-17
00889797107679Made-To-OrderSMS00456SMS004562022-12-08
00889797108188Made-To-OrderSMS00494SMS004942022-12-08

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