MBA™ Titanium Subtalar Implant System 050208

GUDID M2480502081

TRIAL MBA SIZE 8MM

Ascension Orthopedics, Inc.

Orthopaedic prosthesis implantation instrument, reusable
Primary Device IDM2480502081
NIH Device Record Key8b57ea14-c5f0-44bf-9682-0f4b2ec8f5a3
Commercial Distribution StatusIn Commercial Distribution
Brand NameMBA™ Titanium Subtalar Implant System
Version Model Number050208
Catalog Number050208
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
GS110381780280514 [Primary]
HIBCCM2480502081 [Secondary]

FDA Product Code

LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M2480502081]

Moist Heat or Steam Sterilization

[M2480502081]

Moist Heat or Steam Sterilization

[M2480502081]

Moist Heat or Steam Sterilization

[M2480502081]

Moist Heat or Steam Sterilization

[M2480502081]

Moist Heat or Steam Sterilization

[M2480502081]

Moist Heat or Steam Sterilization

[M2480502081]

Moist Heat or Steam Sterilization

[M2480502081]

Moist Heat or Steam Sterilization

[M2480502081]

Moist Heat or Steam Sterilization

[M2480502081]

Moist Heat or Steam Sterilization

[M2480502081]

Moist Heat or Steam Sterilization

[M2480502081]

Moist Heat or Steam Sterilization

[M2480502081]

Moist Heat or Steam Sterilization

[M2480502081]

Moist Heat or Steam Sterilization

[M2480502081]

Moist Heat or Steam Sterilization

[M2480502081]

Moist Heat or Steam Sterilization

[M2480502081]

Moist Heat or Steam Sterilization

[M2480502081]

Moist Heat or Steam Sterilization

[M2480502081]

Moist Heat or Steam Sterilization

[M2480502081]

Moist Heat or Steam Sterilization

[M2480502081]

Moist Heat or Steam Sterilization

[M2480502081]

Moist Heat or Steam Sterilization

[M2480502081]

Moist Heat or Steam Sterilization

[M2480502081]

Moist Heat or Steam Sterilization

[M2480502081]

Moist Heat or Steam Sterilization

[M2480502081]

Moist Heat or Steam Sterilization

[M2480502081]

Moist Heat or Steam Sterilization

[M2480502081]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-03-04
Device Publish Date2018-04-13

On-Brand Devices [MBA™ Titanium Subtalar Implant System]

M248MBAIMP1MBA Implant Set
M2480502121TRIAL MBA SIZE 12MM
M2480502101TRIAL MBA SIZE 10MM
M2480502091TRIAL MBA SIZE 9MM
M2480502081TRIAL MBA SIZE 8MM
M2480502061TRIAL MBA SIZE 6MM
M2480510201MBA™ Titanium Subtalar Implant System CANNULATED INSERTION TOOL
M2480510121MBA™ Titanium Subtalar Implant System 12MM SIZER CANNULATED
M2480510101MBA™ Titanium Subtalar Implant System 10MM SIZER CANNULATED
M2480510091MBA™ Titanium Subtalar Implant System 9MM SIZER CANNULATED
M2480510081MBA™ Titanium Subtalar Implant System 8MM SIZER CANNULATED
M2480510061MBA™ Titanium Subtalar Implant System 6MM SIZER CANNULATED
M2480500171MBA™ Titanium Subtalar Implant System GUIDE PIN 2MM/.078 DIAMETER
M2480500161MBA™ Titanium Subtalar Implant System GUIDE PIN INSERT HOLDER
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.