Identity
- Trade Name
- Resolve Modular Revision Stem EUDAMEDFDA UDI
- Generic Name
- Medullary canal orthopaedic reamer, rigid FDA UDI
- Device Name
- Resolve taper reamer, Ø14×140mm EUDAMEDFDA UDI
- Model / Reference
- 9112-3014 EUDAMEDFDA UDI
- Description
- Resolve taper reamer, Ø14×140mm FDA UDI
Identifiers
- Catalog Number
- 9112-3014 FDA UDI
- Primary DI / UDI-DI
- 04719886902457 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04719886902457 EUDAMED
- FDA Product Code
- HTO FDA UDI
- EMDN Code
- L091102 ORTHOPAEDIC PROSTHESES REAMERS AND BURS, REUSABLE EUDAMED
- GMDN Term
- Medullary canal orthopaedic reamer, rigid 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: Medullary canal orthopaedic reamer, rigid
Resolve Modular Revision Stem by United Orthopedic Corp. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Medullary canal orthopaedic reamer, rigid.
- POLARSTEM — Smith & Nephew, Inc. · Class II
- Intramedullary Reamer, Revision — TOTAL JOINT ORTHOPEDICS, INC. · Class I
- INSTRUMENT — Howmedica Osteonics Corp. · Class I
- Comprehensive® Shoulder Instruments — Biomet Orthopedics, Inc. · Class II
- MP Reconstruction System - Instruments — WALDEMAR LINK GmbH & Co. KG · Class I
- Panta® 2 — Ascension Orthopedics, Inc. · Class I
- Legion — Smith & Nephew, Inc. · Class II
- INSTRUMENT — Howmedica Osteonics Corp. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- United Orthopedic Corp.
Sources (2)
- FDA UDI 72e03e51-9c94-422b-a544-1c4ff20f8cd6 35 fields · synced Oct 6, 2026
- EUDAMED 3896083a-8af5-4285-8e37-430f3d34076a 61 fields · synced Oct 6, 2026