Primary Device ID | M2480150041 |
NIH Device Record Key | 2a57138f-b23a-47b6-9098-e219a4376494 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | KGTI™ Kinetik Great Toe Implant System |
Version Model Number | 015004 |
Catalog Number | 015004 |
Company DUNS | 942377524 |
Company Name | Ascension Orthopedics, Inc. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10381780279785 [Primary] |
HIBCC | M2480150041 [Secondary] |
LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
Steralize Prior To Use | true |
Device Is Sterile | false |
[M2480150041]
Moist Heat or Steam Sterilization
[M2480150041]
Moist Heat or Steam Sterilization
[M2480150041]
Moist Heat or Steam Sterilization
[M2480150041]
Moist Heat or Steam Sterilization
[M2480150041]
Moist Heat or Steam Sterilization
[M2480150041]
Moist Heat or Steam Sterilization
[M2480150041]
Moist Heat or Steam Sterilization
[M2480150041]
Moist Heat or Steam Sterilization
[M2480150041]
Moist Heat or Steam Sterilization
[M2480150041]
Moist Heat or Steam Sterilization
[M2480150041]
Moist Heat or Steam Sterilization
[M2480150041]
Moist Heat or Steam Sterilization
[M2480150041]
Moist Heat or Steam Sterilization
[M2480150041]
Moist Heat or Steam Sterilization
[M2480150041]
Moist Heat or Steam Sterilization
[M2480150041]
Moist Heat or Steam Sterilization
[M2480150041]
Moist Heat or Steam Sterilization
[M2480150041]
Moist Heat or Steam Sterilization
[M2480150041]
Moist Heat or Steam Sterilization
[M2480150041]
Moist Heat or Steam Sterilization
[M2480150041]
Moist Heat or Steam Sterilization
[M2480150041]
Moist Heat or Steam Sterilization
[M2480150041]
Moist Heat or Steam Sterilization
[M2480150041]
Moist Heat or Steam Sterilization
[M2480150041]
Moist Heat or Steam Sterilization
[M2480150041]
Moist Heat or Steam Sterilization
[M2480150041]
Moist Heat or Steam Sterilization
[M2480150041]
Moist Heat or Steam Sterilization
[M2480150041]
Moist Heat or Steam Sterilization
[M2480150041]
Moist Heat or Steam Sterilization
[M2480150041]
Moist Heat or Steam Sterilization
[M2480150041]
Moist Heat or Steam Sterilization
[M2480150041]
Moist Heat or Steam Sterilization
[M2480150041]
Moist Heat or Steam Sterilization
[M2480150041]
Moist Heat or Steam Sterilization
[M2480150041]
Moist Heat or Steam Sterilization
[M2480150041]
Moist Heat or Steam Sterilization
[M2480150041]
Moist Heat or Steam Sterilization
[M2480150041]
Moist Heat or Steam Sterilization
[M2480150041]
Moist Heat or Steam Sterilization
[M2480150041]
Moist Heat or Steam Sterilization
[M2480150041]
Moist Heat or Steam Sterilization
[M2480150041]
Moist Heat or Steam Sterilization
[M2480150041]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2021-03-04 |
Device Publish Date | 2018-04-10 |
M2480150541 | METATARSAL BROACH LEFT POWER |
M2480150521 | METATARSAL BROACH RIGHT POWER |
M2480151161 | TRIAL SIZE 3 PHALANGEAL |
M2480151141 | TRIAL SIZE 2 PHALANGEAL |
M2480151121 | TRIAL SIZE 1 PHALANGEAL |
M2480151101 | TRIAL SIZE 0 PHALANGEAL |
M2480151061 | TRIAL SIZE 3 METATARSAL |
M2480151041 | TRIAL SIZE 2 METATARSAL |
M2480151021 | TRIAL SIZE 1 METATARSAL |
M2480150701 | METATARSAL IMPACTOR |
M2480150551 | METATARSAL BROACH LEFT MANUAL |
M2480150531 | METATARSAL BROACH RIGHT MANUAL |
M2480150431 | METATARSAL BROACH GUIDE LEFT |
M2480150411 | METATARSAL BROACH GUIDE RIGHT |
M2480150321 | DORSAL FLANGE RESECTION GUIDE |
M2480150221 | PHALANGEAL SIZER DRILL GUIDE |
M2480150201 | METATARSAL SIZER DRILL GUIDE |
M2480150141 | INSTRUMENT HANDLE 90º |
M2480150101 | INSTRUMENT HANDLE SMALL |
M2480150041 | PRIMARY RESECTION GUIDE 5MM |
M2480150021 | PRIMARY RESECTION GUIDE NEUTRAL |
M2480150011 | KGTI STERILIZATION CASE |
M2480120101 | The KGTI phalangeal component is fixed by means of a stem, which is inserted into the medullary |
M2480120031 | The KGTI metatarsal implant is spherical and extends from the plantar base of the metatarsal hea |