Identity
- Trade Name
- Resolve Modular Revision Stem EUDAMEDFDA UDI
- Generic Name
- Medullary canal orthopaedic reamer, flexible FDA UDI
- Device Name
- Flexible reamer head, Ø27mm EUDAMEDFDA UDI
- Model / Reference
- 9104-3527 EUDAMEDFDA UDI
- Description
- Flexible reamer head, Ø27mm FDA UDI
Identifiers
- Catalog Number
- 9104-3527 FDA UDI
- Primary DI / UDI-DI
- 04719886903416 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04719886903416 EUDAMED
- FDA Product Code
- HTO FDA UDI
- EMDN Code
- L091102 ORTHOPAEDIC PROSTHESES REAMERS AND BURS, REUSABLE EUDAMED
- GMDN Term
- Medullary canal orthopaedic reamer, flexible FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- France 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Acetabular orthopaedic reamer
Resolve Modular Revision Stem by United Orthopedic Corporation — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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
- ACETABULAR REAMER D53 mm HC — HPF SRL · 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
- ACETABULAR REAMER D82 mm HC — HPF SRL · Class I
- iTotal® Hip Replacement System — Conformis, Inc. · Class II
- M.B.T. — DePuy Ireland UC · Class IIa
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04719886903416 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- United Orthopedic Corporation
- EUDAMED SRN
- TW-MF-000009523
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (2)
- EUDAMED 5867a5d0-b28c-44f6-8a70-d66b89ce4d59 61 fields · synced Jul 9, 2026
- FDA UDI 9ae63375-1ff5-4546-a509-ba2f62975955 35 fields · synced May 30, 2026