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Delta Xtend
EUDAMEDFDA UDIClass I (EU MDR)
Ref 2307-74-008Model Orthopaedic Reamer Guide
Identity
- Trade Name
- DELTA XTEND EUDAMEDFDA UDI
- Generic Name
- Orthopaedic reamer guide FDA UDI
- Device Name
- Orthopaedic Reamer Guide EUDAMEDDELTA Xtend PROXIMAL REAMING GUIDE DIA 8 MM FDA UDI
- Model / Reference
- Orthopaedic Reamer Guide EUDAMED2307-74-008 EUDAMEDFDA UDI
- Description
- DELTA Xtend PROXIMAL REAMING GUIDE DIA 8 MM FDA UDI
Identifiers
- Catalog Number
- 230774008 FDA UDI
- Primary DI / UDI-DI
- 10603295116141 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a004278W EUDAMED
- Direct Marketing DI
- 10603295116141 EUDAMED
- 510(k) Number
- K170748 FDA UDI
- FDA Product Code
- PHX FDA UDIKWS FDA UDIHSD FDA UDI
- EMDN Code
- L090999 ORTHOPAEDIC SURGERY CUTTING INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Orthopaedic reamer guide FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3660 FDA UDI888.3690 FDA UDI
- Market of Registration
- Ireland 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
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
No
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
No
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: Bone cutting forceps, reusable
Delta Xtend by DePuy Ireland UC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0603295a004278W | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- DePuy Ireland UC
- EUDAMED SRN
- IE-MF-000007377
Sources (2)
- EUDAMED e31e6631-2e3d-45b3-91b5-3d3375d3a0be 61 fields · synced May 30, 2026
- FDA UDI 75ca4f2d-5eaf-445a-a68d-b93559227281 36 fields · synced May 29, 2026