| Primary Device ID | M2480510121 |
| NIH Device Record Key | b226a4e9-3449-4acf-b721-9dcb3c2c40d2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MBA™ Titanium Subtalar Implant System |
| Version Model Number | 051012 |
| Catalog Number | 051012 |
| 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 |
| 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 | 10381780280477 [Primary] |
| HIBCC | M2480510121 [Secondary] |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M2480510121]
Moist Heat or Steam Sterilization
[M2480510121]
Moist Heat or Steam Sterilization
[M2480510121]
Moist Heat or Steam Sterilization
[M2480510121]
Moist Heat or Steam Sterilization
[M2480510121]
Moist Heat or Steam Sterilization
[M2480510121]
Moist Heat or Steam Sterilization
[M2480510121]
Moist Heat or Steam Sterilization
[M2480510121]
Moist Heat or Steam Sterilization
[M2480510121]
Moist Heat or Steam Sterilization
[M2480510121]
Moist Heat or Steam Sterilization
[M2480510121]
Moist Heat or Steam Sterilization
[M2480510121]
Moist Heat or Steam Sterilization
[M2480510121]
Moist Heat or Steam Sterilization
[M2480510121]
Moist Heat or Steam Sterilization
[M2480510121]
Moist Heat or Steam Sterilization
[M2480510121]
Moist Heat or Steam Sterilization
[M2480510121]
Moist Heat or Steam Sterilization
[M2480510121]
Moist Heat or Steam Sterilization
[M2480510121]
Moist Heat or Steam Sterilization
[M2480510121]
Moist Heat or Steam Sterilization
[M2480510121]
Moist Heat or Steam Sterilization
[M2480510121]
Moist Heat or Steam Sterilization
[M2480510121]
Moist Heat or Steam Sterilization
[M2480510121]
Moist Heat or Steam Sterilization
[M2480510121]
Moist Heat or Steam Sterilization
[M2480510121]
Moist Heat or Steam Sterilization
[M2480510121]
Moist Heat or Steam Sterilization
[M2480510121]
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 | 2018-04-13 |
| M248MBAIMP1 | MBA Implant Set |
| M2480502121 | TRIAL MBA SIZE 12MM |
| M2480502101 | TRIAL MBA SIZE 10MM |
| M2480502091 | TRIAL MBA SIZE 9MM |
| M2480502081 | TRIAL MBA SIZE 8MM |
| M2480502061 | TRIAL MBA SIZE 6MM |
| M2480510201 | MBA™ Titanium Subtalar Implant System CANNULATED INSERTION TOOL |
| M2480510121 | MBA™ Titanium Subtalar Implant System 12MM SIZER CANNULATED |
| M2480510101 | MBA™ Titanium Subtalar Implant System 10MM SIZER CANNULATED |
| M2480510091 | MBA™ Titanium Subtalar Implant System 9MM SIZER CANNULATED |
| M2480510081 | MBA™ Titanium Subtalar Implant System 8MM SIZER CANNULATED |
| M2480510061 | MBA™ Titanium Subtalar Implant System 6MM SIZER CANNULATED |
| M2480500171 | MBA™ Titanium Subtalar Implant System GUIDE PIN 2MM/.078 DIAMETER |
| M2480500161 | MBA™ Titanium Subtalar Implant System GUIDE PIN INSERT HOLDER |