Integra® DigiFuse® Implant System
- Primary DI
- 10381780074281
- Brand
- Integra® DigiFuse® Implant System
- Company
- Ascension Orthopedics, Inc.
- Model
- DIGIFUSEIMP2
- Catalog number
- DIGIFUSEIMP2
- Device description
- 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.
- Published
- 2015-09-22
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
Contact Domains#
Product Codes#
| Code | Name |
|---|---|
| HWC | Screw, fixation, bone |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | Orthopedic | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K111536 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10381780074281 | Primary | GS1 | 0 | |
| M268DIGIFUSEIMP21 | Secondary | HIBCC | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 10381780074281 | 10381780074281 |
GMDN Terms#
| Term | Definition |
|---|---|
| Orthopaedic bone screw, non-bioabsorbable, non-sterile | "A small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A ""lag screw"" can be any of these used to obtain compression. This device must be sterilized prior to use." |
Sterilization Methods#
| Method |
|---|
| Moist Heat or Steam Sterilization |
Contacts#
| Phone | |
|---|---|
| +1(800)654-2873 | custsvcnj@integralife.com |
Regulatory Flags#
- DUNS number
- 942377524
- Device count
- 1
- Kit
- true
- Serial number
- true
- Sterilization required before use
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 10381780240310 | Cadence™ | 10203193 | 2016-08-24 | |
| 10381780245513 | BioMotion® Cannulated 1st MPJ Hemi System | HM 3010 | HM 3010 | 2017-09-05 |
| 10381780245629 | Titan™ | IP0920055001 | IMP-0920-055-001 | 2017-09-05 |
| 10381780245636 | Titan™ | IP0920064001 | IMP-0920-064-001 | 2017-09-05 |
| 10381780245643 | Titan™ | IP0920079501 | IMP-0920-0795-01 | 2017-09-05 |
| 10381780245650 | Titan™ | IMP096006401 | IMP-0960-064-01 | 2017-09-05 |
| 10381780245667 | Titan™ | IMP096006601 | IMP-0960-066-01 | 2017-09-05 |
| 10381780245674 | Titan™ | IMP096007101 | IMP-0960-071-01 | 2017-09-05 |
| 10381780245681 | Ascension® | IMP10000D | IMP-100-00D | 2017-09-05 |
| 10381780245698 | Ascension® | IMP10000P | IMP-100-00P | 2017-09-05 |
| 10381780245704 | Integra® | IMP20000D | IMP-200-00D | 2017-09-05 |
| 10381780245711 | Integra® | IMP20000P | IMP-200-00P | 2017-09-05 |
| 10381780245728 | Integra® | IMP30000 | IMP-300-00 | 2017-09-05 |
| 10381780245735 | Integra® | IMP35000 | IMP-350-00 | 2017-09-05 |
| 10381780245759 | NuGrip® CMC Implant System | IMP44200 | IMP-442-00 | 2017-09-05 |
| 10381780245766 | First Choice® DRUJ System | IMP60000 | IMP-600-00 | 2017-09-05 |
| 10381780245780 | Movement® | IMP-890-00MT | IMP-890-00MT | 2017-09-05 |
| 10381780245797 | Movement® | IMP-890-00PP | IMP-890-00PP | 2017-09-05 |
| 10381780245803 | Integra® | IMP90001 | IMP-900-01 | 2017-09-05 |
| 10381780245988 | Integra® | MAL092008501 | MAL-0920-085-01 | 2017-08-30 |
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