Integra® DigiFuse® Implant System DIGIFUSEIMP2
GUDID M268DIGIFUSEIMP21
The Integra DigiFuse Implant is a one-piece threaded device intended to be implanted into the medullary bone of the lesser toes. The implant is offered in several variations consisting of the combination of 2.0mm and 2.5mm, 0° and 10° blades, as well as standard and short blade options. A 2.0mm x 0° mini-blade is also offered for DIP fusions and smaller anatomy. The system includes instruments to facilitate the placement of the implants. All implants are made from Titanium Alloy, and instrumentation is made from titanium and stainless steel. The DigiFuse implant is indicated for the fixation of osteotomies and reconstruction of the lesser phalanges during procedures to correct deformities of the toes and fingers.
Ascension Orthopedics, Inc.
Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile| Primary Device ID | M268DIGIFUSEIMP21 |
| NIH Device Record Key | f392e211-a61f-4a58-a383-0bb6b6395460 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Integra® DigiFuse® Implant System |
| Version Model Number | DIGIFUSEIMP2 |
| Catalog Number | DIGIFUSEIMP2 |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10381780074281 [Primary] |
| HIBCC | M268DIGIFUSEIMP21 [Secondary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K111536
FDA Product Code
| HWC | Screw, fixation, bone |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M268DIGIFUSEIMP21]
Moist Heat or Steam Sterilization
[M268DIGIFUSEIMP21]
Moist Heat or Steam Sterilization
[M268DIGIFUSEIMP21]
Moist Heat or Steam Sterilization
[M268DIGIFUSEIMP21]
Moist Heat or Steam Sterilization
[M268DIGIFUSEIMP21]
Moist Heat or Steam Sterilization
[M268DIGIFUSEIMP21]
Moist Heat or Steam Sterilization
[M268DIGIFUSEIMP21]
Moist Heat or Steam Sterilization
[M268DIGIFUSEIMP21]
Moist Heat or Steam Sterilization
[M268DIGIFUSEIMP21]
Moist Heat or Steam Sterilization
[M268DIGIFUSEIMP21]
Moist Heat or Steam Sterilization
[M268DIGIFUSEIMP21]
Moist Heat or Steam Sterilization
[M268DIGIFUSEIMP21]
Moist Heat or Steam Sterilization
[M268DIGIFUSEIMP21]
Moist Heat or Steam Sterilization
[M268DIGIFUSEIMP21]
Moist Heat or Steam Sterilization
[M268DIGIFUSEIMP21]
Moist Heat or Steam Sterilization
[M268DIGIFUSEIMP21]
Moist Heat or Steam Sterilization
[M268DIGIFUSEIMP21]
Moist Heat or Steam Sterilization
[M268DIGIFUSEIMP21]
Moist Heat or Steam Sterilization
[M268DIGIFUSEIMP21]
Moist Heat or Steam Sterilization
[M268DIGIFUSEIMP21]
Moist Heat or Steam Sterilization
[M268DIGIFUSEIMP21]
Moist Heat or Steam Sterilization
[M268DIGIFUSEIMP21]
Moist Heat or Steam Sterilization
[M268DIGIFUSEIMP21]
Moist Heat or Steam Sterilization
[M268DIGIFUSEIMP21]
Moist Heat or Steam Sterilization
[M268DIGIFUSEIMP21]
Moist Heat or Steam Sterilization
[M268DIGIFUSEIMP21]
Moist Heat or Steam Sterilization
[M268DIGIFUSEIMP21]
Moist Heat or Steam Sterilization
[M268DIGIFUSEIMP21]
Moist Heat or Steam Sterilization
[M268DIGIFUSEIMP21]
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 | 2015-09-22 |
Devices Manufactured by Ascension Orthopedics, Inc.
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| M269AW32051 - CAPTURE™ | 2023-11-09 CAPTURE™ High Torque Screw System The cannula cleaning stylet is used to clean all cannulated instruments. This instrument is |
| 10381780123026 - CAPTURE™ High Torque Screw System | 2023-09-18 The washer is used in conjunction with the Capture High Torque Screw System. |
| 10381780123033 - CAPTURE™ High Torque Screw System | 2023-09-18 The washer is used in conjunction with the Capture High Torque Screw System. |
| 10381780123040 - CAPTURE™ High Torque Screw System | 2023-09-18 The washer is used in conjunction with the Capture High Torque Screw System. |
| 10381780123057 - CAPTURE™ High Torque Screw System | 2023-09-18 The washer is used in conjunction with the Capture High Torque Screw System. |
| 10381780123064 - CAPTURE™ High Torque Screw System | 2023-09-18 The washer is used in conjunction with the Capture High Torque Screw System. |
| M26922286111 - Integra® | 2023-09-18 Integra® Total Foot System K-Wire is used for temporary fixation. |
Trademark Results [Integra]
© 2024 FDA.report
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