ACETABULAR REAMER EVO D62 mm
FDA UDIEUDAMEDClass I (US FDA UDI)
by Hpf Srl
Identity
- Trade Name
- ACETABULARRIVAL EVO D62 mm EUDAMEDACETABULAR REAMER EVO D62 mm FDA UDI
- Generic Name
- Acetabular orthopaedic reamer FDA UDI
- Model / Reference
- H0035556299 EUDAMEDFDA UDIACETABULAR REAMER EVO EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08057968715912 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08057968715912 EUDAMED
- FDA Product Code
- HWE FDA UDI
- EMDN Code
- L091102 ORTHOPAEDIC PROSTHESES REAMERS AND BURS, REUSABLE EUDAMED
- GMDN Term
- Acetabular orthopaedic reamer FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
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
No
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
No
Manufacturing Date
Yes
Category: Acetabular orthopaedic reamer
The ACETABULAR REAMER EVO D62 mm device is a precision orthopaedic surgical instrument designed to cut and resurface with accuracy the acetabulum for the acceptance of the acetabular component of a hip joint prosthesis. This reusable device, made from high-grade stainless steel alloy, features a hemispherical shell with an abrasive outer surface as the cutting head attached to a shaft for manual or powered rotation.
Similar devices
Also classified as Acetabular orthopaedic reamer.
- Acetabular Reamer Driver, Straight — TOTAL JOINT ORTHOPEDICS, INC. · Class I
- Viant Medical, LLC — Viant Medical, LLC · Class I
- Flexible Reamer Ø14 — NORMMED MEDİKAL SAN. VE TİC. A.Ş. · Class I
- Cormet 2000 Hemi-Hip Metallic Resurfacing Prosthesis — CORIN LTD · Class II
- iTotal® Hip Replacement System — Conformis, Inc. · Class II
- M.B.T. — DePuy Ireland UC · Class IIa
- U2 Total Knee System — United Orthopedic Corporation · Class IIa
- b-ONE™ Primary Acetabular System — b-ONE Ortho Corp. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Hpf Srl
Sources (2)
- FDA UDI 7bee5e35-043b-4ec5-b4ab-e2de445df11e 32 fields · synced Jul 29, 2026
- EUDAMED d738a9f5-6e44-4199-a1af-c046358e8b74 61 fields · synced Jun 18, 2026