Argo Knotless
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- Argo Knotless EUDAMEDFDA UDI
- Generic Name
- Bone tap, single-use FDA UDIBone-coring punch, single-use FDA UDIOrthopaedic broach FDA UDIBone tap, reusable FDA UDIFluted surgical drill bit, single-use FDA UDI
- Device Name
- Disposable Surgical Instruments EUDAMEDOrthopedic, Non-active, Drill Bit, Sterile, Disposable, General EUDAMEDOrthopedic, Non-Active, Tap, Disposable, Argo Knotless EUDAMEDOrthopedic, Non-active, Reusable Surgical Instrument, Cutting EUDAMEDReusable Manual Surgical Instruments EUDAMED5.5 mm Argo Knotless Disposable Tap FDA UDI4.75/5.5 mm Argo Knotless Disposable Broaching Punch FDA UDI4.75/5.5 mm Argo Knotless Reusable Broaching Punch FDA UDI4.75 mm Argo Knotless Reusable Tap FDA UDI4.75/5.5 mm Argo Knotless Disposable Drill Bit FDA UDI
- Model / Reference
- K4755DBP EUDAMEDFDA UDIK4755D EUDAMEDFDA UDIK55DTAP EUDAMEDFDA UDIK4755RBP EUDAMEDFDA UDIK475RTAP EUDAMEDFDA UDI
- Description
- 5.5 mm Argo Knotless Disposable Tap FDA UDI4.75/5.5 mm Argo Knotless Disposable Broaching Punch FDA UDI4.75/5.5 mm Argo Knotless Reusable Broaching Punch FDA UDI4.75 mm Argo Knotless Reusable Tap FDA UDI4.75/5.5 mm Argo Knotless Disposable Drill Bit FDA UDI
Identifiers
- Catalog Number
- K55DTAP FDA UDIK4755DBP FDA UDIK4755RBP FDA UDIK475RTAP FDA UDIK4755D FDA UDI
- Primary DI / UDI-DI
- 20845854649845 EUDAMEDFDA UDI20845854649852 EUDAMEDFDA UDI20845854650209 EUDAMEDFDA UDI30845854083233 EUDAMEDFDA UDI30653405988360 EUDAMEDFDA UDI
- Basic UDI-DI
- 084585408666DY EUDAMED084585408634DK EUDAMED084585408646DS EUDAMED084585464942F7 EUDAMEDB-30653405988360 EUDAMED
- Direct Marketing DI
- 10845854083239 EUDAMED
- FDA Product Code
- HWX FDA UDILXH FDA UDIGFG FDA UDI
- EMDN Code
- P091399 ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER EUDAMEDZ12139085 VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS - CONSUMABLES EUDAMEDL0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMEDL090999 ORTHOPAEDIC SURGERY CUTTING INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Bone tap, single-use FDA UDIBone-coring punch, single-use FDA UDIOrthopaedic broach FDA UDIBone tap, reusable FDA UDIFluted surgical drill bit, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI878.4820 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Joint prosthesis implantation kit, single-use
Argo Knotless by Conmed Corporation — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 084585408666DY | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 084585408666DY | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Conmed Corporation
- EUDAMED SRN
- US-MF-000012663
- Authorised Representative
- Conmed Europe BV BE-AR-000035662
Sources (13)
- EUDAMED 3d94f889-3935-4341-bd3e-27b1a7c3b1a5 61 fields · synced Jul 20, 2026
- EUDAMED 38bba0a9-a1c2-4d9a-ad57-6ee4d2852599 61 fields · synced May 17, 2026
- EUDAMED 9a48a9b6-aa20-4e4b-9624-dc6a171c1182 61 fields · synced May 18, 2026
- FDA UDI 1416a0a2-347a-45cd-97be-9bf8772962cb 36 fields · synced May 30, 2026
- FDA UDI c6ddf631-a30a-46e3-b948-c1475a30e3f0 37 fields · synced May 30, 2026
- FDA UDI f59f8aaf-4b42-4755-a5a8-a9860f50d195 36 fields · synced May 30, 2026
- FDA UDI 6534f80e-d290-4a21-a38c-cf73bc9f66ed 36 fields · synced May 30, 2026
- FDA UDI 4a0d1338-0733-434c-b896-bcab2c3906fa 37 fields · synced May 30, 2026
- EUDAMED 0531d57d-cdc4-4e6c-abba-6baa28dd651e 61 fields · synced Jul 13, 2026
- EUDAMED b4ed2c8e-f69e-4585-b0a9-ec991b3daf98 61 fields · synced Jul 16, 2026
- EUDAMED 373a7ba6-dad4-45de-b8ac-2ff19af9d58d 61 fields · synced Jul 16, 2026
- EUDAMED 08862b23-4a2f-4d29-a81a-c483c082c818 61 fields · synced Jul 17, 2026
- EUDAMED 562b770f-c289-47fe-a79c-8010d88405f7 61 fields · synced Jul 20, 2026