Integra® MemoFix® STAPLEIMP
GUDID M268STAPLEIMP1
The Integra MemoFix staple is a one piece single use nickel titanium alloy bone fixation device intended to be permanently implanted. The device is indicated for the fixation of osteotomies and joint arthrodesis of the hands and feet. The implant consists of two legs connected by a bridge and is offered in multiple combinations of bridge widths and leg lengths to accommodate various anatomies. The system includes instruments, made from titanium and stainless steel, to facilitate the placement of the implants.
Ascension Orthopedics, Inc.
Orthopaedic bone staple, non-adjustable, non-sterile| Primary Device ID | M268STAPLEIMP1 |
| NIH Device Record Key | 10133d7e-1afd-43fe-ba67-44fc3ad8aff9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Integra® MemoFix® |
| Version Model Number | STAPLEIMP |
| Catalog Number | STAPLEIMP |
| Company DUNS | 942377524 |
| Company Name | Ascension Orthopedics, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| 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 |
Customer Support Contacts
| 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 | |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10381780074298 [Primary] |
| HIBCC | M268STAPLEIMP1 [Secondary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K123926
FDA Product Code
| JDR | STAPLE, FIXATION, BONE |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
[M268STAPLEIMP1]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-07-16 |
| Device Publish Date | 2015-09-26 |
On-Brand Devices [Integra® MemoFix®]
| M268STAPLEIMP1 | The Integra MemoFix staple is a one piece single use nickel titanium alloy bone fixation device |
| M268MS2522221 | The Integra® MemoFix® staple is a one piece single use nickel titanium alloy bone fixation dev |
| M268MS2520201 | The Integra® MemoFix® staple is a one piece single use nickel titanium alloy bone fixation dev |
| M268MS2020201 | The Integra® MemoFix® staple is a one piece single use nickel titanium alloy bone fixation dev |
| M268MS2015151 | The Integra® MemoFix® staple is a one piece single use nickel titanium alloy bone fixation dev |
| M268MS1819171 | The Integra® MemoFix® staple is a one piece single use nickel titanium alloy bone fixation dev |
| M268MS1817151 | The Integra® MemoFix® staple is a one piece single use nickel titanium alloy bone fixation dev |
| M268MS1814141 | The Integra® MemoFix® staple is a one piece single use nickel titanium alloy bone fixation dev |
| M268MS1812121 | The Integra® MemoFix® staple is a one piece single use nickel titanium alloy bone fixation dev |
| M268MS1515151 | The Integra® MemoFix® staple is a one piece single use nickel titanium alloy bone fixation dev |
| M268MS1512121 | The Integra® MemoFix® staple is a one piece single use nickel titanium alloy bone fixation dev |
| M268MS1219161 | The Integra® MemoFix® staple is a one piece single use nickel titanium alloy bone fixation dev |
| M268MS1217151 | The Integra® MemoFix® staple is a one piece single use nickel titanium alloy bone fixation dev |
| M268MS1215131 | The Integra® MemoFix® staple is a one piece single use nickel titanium alloy bone fixation dev |
| M268MS1210101 | The Integra® MemoFix® staple is a one piece single use nickel titanium alloy bone fixation dev |
| M268MS1017151 | The Integra® MemoFix® staple is a one piece single use nickel titanium alloy bone fixation dev |
| M268MS1015131 | The Integra® MemoFix® staple is a one piece single use nickel titanium alloy bone fixation dev |
| M268MS1010101 | The Integra® MemoFix® staple is a one piece single use nickel titanium alloy bone fixation dev |
| M268MS0808081 | The Integra® MemoFix® staple is a one piece single use nickel titanium alloy bone fixation dev |
Trademark Results [Integra]
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