KGTI™ Kinetik Great Toe Implant System 015112

GUDID M2480151121

TRIAL SIZE 1 PHALANGEAL

Ascension Orthopedics, Inc.

Orthopaedic prosthesis implantation instrument, reusable
Primary Device IDM2480151121
NIH Device Record Key03fd1348-26a7-4288-afbe-5675fa88d6f5
Commercial Distribution StatusIn Commercial Distribution
Brand NameKGTI™ Kinetik Great Toe Implant System
Version Model Number015112
Catalog Number015112
Company DUNS942377524
Company NameAscension Orthopedics, 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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS110381780279976 [Primary]
HIBCCM2480151121 [Secondary]

FDA Product Code

LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M2480151121]

Moist Heat or Steam Sterilization

[M2480151121]

Moist Heat or Steam Sterilization

[M2480151121]

Moist Heat or Steam Sterilization

[M2480151121]

Moist Heat or Steam Sterilization

[M2480151121]

Moist Heat or Steam Sterilization

[M2480151121]

Moist Heat or Steam Sterilization

[M2480151121]

Moist Heat or Steam Sterilization

[M2480151121]

Moist Heat or Steam Sterilization

[M2480151121]

Moist Heat or Steam Sterilization

[M2480151121]

Moist Heat or Steam Sterilization

[M2480151121]

Moist Heat or Steam Sterilization

[M2480151121]

Moist Heat or Steam Sterilization

[M2480151121]

Moist Heat or Steam Sterilization

[M2480151121]

Moist Heat or Steam Sterilization

[M2480151121]

Moist Heat or Steam Sterilization

[M2480151121]

Moist Heat or Steam Sterilization

[M2480151121]

Moist Heat or Steam Sterilization

[M2480151121]

Moist Heat or Steam Sterilization

[M2480151121]

Moist Heat or Steam Sterilization

[M2480151121]

Moist Heat or Steam Sterilization

[M2480151121]

Moist Heat or Steam Sterilization

[M2480151121]

Moist Heat or Steam Sterilization

[M2480151121]

Moist Heat or Steam Sterilization

[M2480151121]

Moist Heat or Steam Sterilization

[M2480151121]

Moist Heat or Steam Sterilization

[M2480151121]

Moist Heat or Steam Sterilization

[M2480151121]

Moist Heat or Steam Sterilization

[M2480151121]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-03-04
Device Publish Date2018-04-10

On-Brand Devices [KGTI™ Kinetik Great Toe Implant System]

M2480150541METATARSAL BROACH LEFT POWER
M2480150521METATARSAL BROACH RIGHT POWER
M2480151161TRIAL SIZE 3 PHALANGEAL
M2480151141TRIAL SIZE 2 PHALANGEAL
M2480151121TRIAL SIZE 1 PHALANGEAL
M2480151101TRIAL SIZE 0 PHALANGEAL
M2480151061TRIAL SIZE 3 METATARSAL
M2480151041TRIAL SIZE 2 METATARSAL
M2480151021TRIAL SIZE 1 METATARSAL
M2480150701METATARSAL IMPACTOR
M2480150551METATARSAL BROACH LEFT MANUAL
M2480150531METATARSAL BROACH RIGHT MANUAL
M2480150431METATARSAL BROACH GUIDE LEFT
M2480150411METATARSAL BROACH GUIDE RIGHT
M2480150321DORSAL FLANGE RESECTION GUIDE
M2480150221PHALANGEAL SIZER DRILL GUIDE
M2480150201METATARSAL SIZER DRILL GUIDE
M2480150141INSTRUMENT HANDLE 90º
M2480150101INSTRUMENT HANDLE SMALL
M2480150041PRIMARY RESECTION GUIDE 5MM
M2480150021PRIMARY RESECTION GUIDE NEUTRAL
M2480150011KGTI STERILIZATION CASE
M2480120101The KGTI phalangeal component is fixed by means of a stem, which is inserted into the medullary
M2480120031The KGTI metatarsal implant is spherical and extends from the plantar base of the metatarsal hea
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.