Identity
- Trade Name
- Bixcut® EUDAMEDBIXCUT FDA UDI
- Generic Name
- Medullary canal orthopaedic reamer, flexible FDA UDI
- Device Name
- BIXCUT - OPENING INSTRUMENTATION - CLASS IIA - NON STERILE EUDAMEDIM Reamer Head with Dovetail FDA UDI
- Model / Reference
- 0226-4275 EUDAMEDFDA UDI08858251002995U4 EUDAMED
- Description
- IM Reamer Head with Dovetail FDA UDI
Identifiers
- Catalog Number
- 0226-4275 FDA UDI
- Primary DI / UDI-DI
- 07613153188483 EUDAMEDFDA UDI
- Basic UDI-DI
- 08858251002995U4 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- P091280 OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS - ACCESSORIES 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
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
Yes
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Medullary canal orthopaedic reamer, flexible
Bixcut by Stryker Corp. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Medullary canal orthopaedic reamer, flexible.
- MODULAR FLEXIBLE REAMER HEAD, Ø10.0mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
- Patella Inlay Reamer Size 5 — SIGNATURE ORTHOPAEDICS PTY LTD · Class I
- ARCOS MODULAR REVISION SYSTEM — Biomet Orthopedics, Inc. · Class II
- ARCOS MODULAR REVISION SYSTEM — Biomet Orthopedics, Inc. · Class II
- Arthrex® — Arthrex, Inc. · Class I
- NITINOL MODULAR REAMER HUDSON — Biomet Orthopedics, Inc. · Class I
- Dyna Locking IM Nail — CG MedTech Co., Ltd. · Class I
- OIC Intramedullary Nail System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | 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
- Stryker Corp.
Sources (2)
- FDA UDI 8d69dcb4-459b-4fc5-a7f2-f9de3d100a64 35 fields · synced Oct 7, 2026
- EUDAMED 1bf3650b-0cfa-400d-a85a-cfd8f4b68f0c 61 fields · synced Oct 7, 2026