Identity
- Trade Name
- Argo Knotless EUDAMEDFDA UDI
- Generic Name
- Orthopaedic broach FDA UDI
- Device Name
- Orthopedic, Non-active, Reusable Surgical Instrument, Punching EUDAMED4.75/5.5 mm Argo Knotless Reusable Tapered Broaching Punch FDA UDI
- Model / Reference
- K4755RTBP EUDAMEDFDA UDI
- Description
- 4.75/5.5 mm Argo Knotless Reusable Tapered Broaching Punch FDA UDI
Identifiers
- Catalog Number
- K4755RTBP FDA UDI
- Primary DI / UDI-DI
- 30653405988377 EUDAMEDFDA UDI
- Basic UDI-DI
- 084585408441D6 EUDAMED
- Direct Marketing DI
- 10653405988373 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L090999 ORTHOPAEDIC SURGERY CUTTING INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Orthopaedic broach FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Bone cutting forceps, reusable
Argo Knotless by Conmed Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 084585408441D6 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Conmed Corporation
- EUDAMED SRN
- US-MF-000012663
- Authorised Representative
- Conmed Europe BV BE-AR-000035662
Sources (2)
- EUDAMED 1d9360e7-4d3d-4c24-badf-d94a9dca5f26 61 fields · synced May 30, 2026
- FDA UDI 7c0cff7a-4aeb-4ef9-81cc-7b163171f724 36 fields · synced May 30, 2026