Identity
- Trade Name
- Incompass Total Ankle System FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- Rotation Guide Slider FDA UDI
- Model / Reference
- 33820012 FDA UDI
- Description
- Rotation Guide Slider FDA UDI
Identifiers
- Catalog Number
- 33820012 FDA UDI
- Primary DI / UDI-DI
- 00889797112291 FDA UDI
- FDA Product Code
- HSN FDA UDI
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3110 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Orthopaedic prosthesis implantation positioning instrument, reusable
The Incompass Total Ankle System is a hand-held surgical instrument designed for orthopedic prosthesis implantation, intended to aid in navigation and placement of prostheses or other instruments. It features a rotation guide slider mechanism that allows for precise control over relative position landmarks, ensuring accurate spatial orientation and limb alignment during procedures.
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Authorization Coverage (1 country)
Regulatory Authorizations
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
- Wright Medical Technology, Inc.
Sources (1)
- FDA UDI 5b533461-b890-4d02-9882-1bcbb4ecabe8 35 fields · synced Jul 11, 2026