Identity
- Trade Name
- Integra® DigiFuse® Implant System FDA UDI
- Generic Name
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
- Device Name
- The Integra® DigiFuse® Implant is a one-piece threaded device constructed from implant grade titanium alloy, intended to be implanted into the medullary bone for the fixation of osteotomies and reconstruction of the lesser phalanges during procedures to correct deformities of the toes and fingers. FDA UDI
- Model / Reference
- DF2010 FDA UDI
- Description
- The Integra® DigiFuse® Implant is a one-piece threaded device constructed from implant grade titanium alloy, intended to be implanted into the medullary bone for the fixation of osteotomies and reconstruction of the lesser phalanges during procedures to correct deformities of the toes and fingers. FDA UDI
Identifiers
- Catalog Number
- DF2010 FDA UDI
- Primary DI / UDI-DI
- 10381780120018 FDA UDI
- 510(k) Number
- K111536 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic bone screw, non-bioabsorbable, non-sterile
Integra® DigiFuse® Implant System by Ascension Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone screw, non-bioabsorbable, non-sterile.
- OIC Cannulated Screw System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
- Monster Screw System — Paragon 28 · Class II
- AOS CAPTURED CORTICAL SCREW, FULLY THREADED 6.5mm x 75mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
- APTUS — Medartis Inc. · Class II
- SMOOTH PEG — Biomet Orthopedics, Inc. · Class II
- AOS CANNULATED CANCELLOUS SCREW, FULLY THREADED 7.0mm x 105mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
- QWIX — Newdeal Sas · Class II
- Monster Screw System — Paragon 28 · Class II
Cleared under the same submission
K111536 also covers:
- Integra® DigiFuse® Implant System — Ascension Orthopedics, Inc.
- Integra® DigiFuse® Implant System — Ascension Orthopedics, Inc.
- Integra® DigiFuse® Implant System — Ascension Orthopedics, Inc.
- Integra® DigiFuse® Implant System — Ascension Orthopedics, Inc.
- Integra® DigiFuse® Implant System — Ascension Orthopedics, Inc.
- Integra® DigiFuse® Implant System — Ascension Orthopedics, Inc.
- DigiFuse Cannulated Intramedullary Fusion — Smith & Nephew, Inc.
- DigiFuse Cannulated Intramedullary Fusion — Smith & Nephew, Inc.
- DigiFuse Cannulated Intramedullary Fusion — Smith & Nephew, Inc.
- DigiFuse Cannulated Intramedullary Fusion — Smith & Nephew, Inc.
- DigiFuse Cannulated Intramedullary Fusion — Smith & Nephew, Inc.
- DigiFuse Cannulated Intramedullary Fusion — Smith & Nephew, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ascension Orthopedics, Inc.
Sources (1)
- FDA UDI 7c793427-6d9d-4512-95ee-c5f821287791 38 fields · synced May 29, 2026