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Delta Xtend
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 2307-70-012Model Surgical Instrument Handle, Non-Torque Limiting
Identity
- Trade Name
- DELTA XTEND EUDAMEDFDA UDI
- Generic Name
- Surgical instrument handle, non-torque-limiting FDA UDI
- Device Name
- Surgical Instrument Handle, Non-Torque Limiting EUDAMEDDELTA Xtend HANDLE FOR CUTTING GUIDE DIA 12 MM FDA UDI
- Model / Reference
- 2307-70-012 EUDAMEDFDA UDISurgical Instrument Handle, Non-Torque Limiting EUDAMED
- Description
- DELTA Xtend HANDLE FOR CUTTING GUIDE DIA 12 MM FDA UDI
Identifiers
- Catalog Number
- 230770012 FDA UDI
- Primary DI / UDI-DI
- 10603295116042 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a004328P EUDAMED
- Direct Marketing DI
- 10603295116042 EUDAMED
- 510(k) Number
- K170748 FDA UDI
- FDA Product Code
- KWS FDA UDIHSD FDA UDIPHX FDA UDI
- EMDN Code
- L091104 ORTHOPAEDIC PROSTHESES POSITIONERS, REUSABLE EUDAMED
- GMDN Term
- Surgical instrument handle, non-torque-limiting 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
Delta Xtend by Depuy (ireland) — Class II — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Cleared under the same submission
K170748 also covers:
- DELTA XTEND — DEPUY (IRELAND)
- GLOBAL UNITE — DEPUY (IRELAND)
- GLOBAL UNITE — DEPUY (IRELAND)
- GLOBAL UNITE — DEPUY (IRELAND)
- GLOBAL UNITE — DEPUY (IRELAND)
- GLOBAL UNITE — DEPUY (IRELAND)
- GLOBAL UNITE — DEPUY (IRELAND)
- GLOBAL UNITE — DEPUY (IRELAND)
- GLOBAL UNITE — DEPUY (IRELAND)
- GLOBAL UNITE — DEPUY (IRELAND)
- GLOBAL UNITE — DEPUY (IRELAND)
- GLOBAL UNITE — DEPUY (IRELAND)
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Depuy (ireland)
Sources (2)
- FDA UDI 63085719-549f-455f-813c-727f7354e73f 36 fields · synced Oct 7, 2026
- EUDAMED dcd369a0-e44a-4394-b6d6-13408cf12dec 61 fields · synced Jul 10, 2026