Identity
- Trade Name
- Radian FDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- Instrument: Drill and Screw Guide Holding Screw. The Radian MIS Bunion System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus. FDA UDI
- Model / Reference
- BUN-1000T-SGHS FDA UDI
- Description
- Instrument: Drill and Screw Guide Holding Screw. The Radian MIS Bunion System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810135961431 FDA UDI
- FDA Product Code
- MDM FDA UDI
- GMDN Term
- General internal orthopaedic fixation system implantation kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
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: General internal orthopaedic fixation system implantation kit
Radian by Nvision Biomedical Technologies, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General internal orthopaedic fixation system implantation kit.
- Matrixx System — NEXXT SPINE LLC · Class I
- Swedge Pedicle Screw Fixation System — SPINAL RESOURCES INC · Class II
- OsteoMed — Osteomed Corp. · Class II
- ACUMED — ACUMED LLC · Class I
- OsteoMed — Osteomed Corp. · Class II
- ALEUTIAN® Interbody Systems — K2M, INC. · Class II
- HONOUR™ Spacer System — NEXXT SPINE LLC · Class II
- CASCADIA™ Interbody System — K2M, INC. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nvision Biomedical Technologies, Inc
Sources (1)
- FDA UDI 8dd81bff-98bb-442a-b9d4-01933a377097 34 fields · synced May 30, 2026