Identity
- Trade Name
- Gripper Hinged Knee ROM FDA UDI
- Generic Name
- Knee support orthosis FDA UDI
- Model / Reference
- 117176 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00802357171767 FDA UDI
- FDA Product Code
- ITQ FDA UDI
- GMDN Term
- Knee support orthosis FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3475 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Knee support orthosis
The Gripper Hinged Knee ROM is a stand-alone, prefabricated orthopaedic appliance designed to support, align, prevent, or correct deformities/injuries or improve function of the knee. It incorporates hinges for improved support and may be used in conjunction with other devices for comprehensive treatment.
Similar devices
Also classified as Knee support orthosis.
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- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Medical Specialties Incorporated
Sources (1)
- FDA UDI 0b038c24-ca91-41a1-a070-23f419fcd4ad 32 fields · synced Oct 6, 2026