Identity
- Trade Name
- DigiFuse Cannulated Intramedullary Fusion FDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Device Name
- DIGIFUSE IMPLANT 2.0MM 10 DEGREE ANGLE SHORT FDA UDI
- Model / Reference
- DF2010S FDA UDI
- Description
- DIGIFUSE IMPLANT 2.0MM 10 DEGREE ANGLE SHORT FDA UDI
Identifiers
- Catalog Number
- DF2010S FDA UDI
- Primary DI / UDI-DI
- 00885556824801 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Orthopaedic bone screw (non-sliding) 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
Yes
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-sliding)
DigiFuse Cannulated Intramedullary Fusion by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone screw (non-sliding).
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- PANGEA — Stryker Corp. · Class II
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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.
- 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.
K152527 also covers:
K210016 also covers:
- Capture Screw System — Smith & Nephew, Inc.
- Capture Screw System — Smith & Nephew, Inc.
- Capture Screw System — Smith & Nephew, Inc.
- Capture Screw System — Smith & Nephew, Inc.
- Capture Screw System — Smith & Nephew, Inc.
- Capture Screw System — Smith & Nephew, Inc.
- Capture Screw System — Smith & Nephew, Inc.
- Capture Screw System — Smith & Nephew, Inc.
- Capture Screw System — Smith & Nephew, Inc.
- Capture Screw System — Smith & Nephew, Inc.
- Capture Screw System — Smith & Nephew, Inc.
- Capture Screw System — 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 |
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Manufacturer
- Manufacturer
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI 5c7858dc-4c69-4e30-9638-f3ac905355c5 37 fields · synced Jun 8, 2026