Identity
- Trade Name
- ORTHOFIX FDA UDI
- Generic Name
- Arthrodesis intramedullary nail, non-distracting FDA UDI
- Device Name
- RODEO TELESCOPIC NAIL L325MM D6.0MM STERILE FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- RODEO TELESCOPIC NAIL L325MM D6.0MM STERILE FDA UDI
Identifiers
- Catalog Number
- 99-67760325R FDA UDI
- Primary DI / UDI-DI
- 18059015373301 FDA UDI
- 510(k) Number
- K232648 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Arthrodesis intramedullary nail, non-distracting FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3020 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 325 Millimeter FDA UDIOuter Diameter — 6 Millimeter FDA UDI
Category: Arthrodesis intramedullary nail, non-distracting
Orthofix by Orthofix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Arthrodesis intramedullary nail, non-distracting.
- AUTOBAHN — GLOBUS MEDICAL, INC. · Class II
- AUTOBAHN — GLOBUS MEDICAL, INC. · Class II
- Reconstruction nail; long, 12×320 mm, 135°, left, cannulated — MEDIN, a.s. · Class IIb
- ZİMED MEDİKAL SANAYİ VE TİCARET LİMİTED ŞİRKETİ — Zimed Medikal Sanayi ve Ticaret Limited Şirketi · Class IIb
- INTREX — Bonetech Medisys Pvt. Ltd. · Class IIb
- Locking Screw — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- Femoral Nail — WUHAN MINDRAY SCIENTIFIC CO., LTD. · Class IIb
- AUTOBAHN — GLOBUS MEDICAL, INC. · Class II
Cleared under the same submission
K232648 also covers:
- ORTHOFIX — Orthofix, Inc.
- ORTHOFIX — Orthofix, Inc.
- ORTHOFIX — Orthofix, Inc.
- ORTHOFIX — Orthofix, Inc.
- ORTHOFIX — Orthofix, Inc.
- ORTHOFIX — Orthofix, Inc.
- ORTHOFIX — Orthofix, Inc.
- ORTHOFIX — Orthofix, Inc.
- ORTHOFIX — Orthofix, Inc.
- ORTHOFIX — Orthofix, Inc.
- ORTHOFIX — Orthofix, Inc.
- ORTHOFIX — Orthofix, 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
- Orthofix, Inc.
Sources (1)
- FDA UDI 976cd497-13eb-4a2b-89fc-42b9ff25606b 37 fields · synced May 31, 2026