Ortho Solutions Trauma Implants For Osteosynthesis
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS FDA UDI
- Generic Name
- Orthopaedic bone wire FDA UDI
- Device Name
- Implantable Wires EUDAMEDK-WIRE DOUBLE TROCAR 1.0MM X 100MM FDA UDI
- Model / Reference
- OS210100 EUDAMEDFDA UDIRods Pins and Wires EUDAMED
- Description
- K-WIRE DOUBLE TROCAR 1.0MM X 100MM FDA UDI
Identifiers
- Catalog Number
- OS210100 FDA UDI
- Primary DI / UDI-DI
- 05055662921830 EUDAMEDFDA UDI
- Basic UDI-DI
- 505566291078 EUDAMED
- 510(k) Number
- K110895 FDA UDI
- FDA Product Code
- HWC FDA UDI
- EMDN Code
- P09120301 KIRSCHNER BONE WIRES EUDAMED
- GMDN Term
- Orthopaedic bone wire FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Orthopaedic bone wire
Ortho Solutions Trauma Implants For Osteosynthesis by Ortho Solutions Holdings Limited — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Cleared under the same submission
K110895 also covers:
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS — ORTHO SOLUTIONS HOLDINGS LIMITED
- ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS — ORTHO SOLUTIONS HOLDINGS LIMITED
- ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS — ORTHO SOLUTIONS HOLDINGS LIMITED
- ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS — ORTHO SOLUTIONS HOLDINGS LIMITED
- ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS — ORTHO SOLUTIONS HOLDINGS LIMITED
- ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS — ORTHO SOLUTIONS HOLDINGS LIMITED
- ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS — ORTHO SOLUTIONS HOLDINGS LIMITED
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ortho Solutions Holdings Limited
Sources (2)
- FDA UDI cac79113-d260-4b24-9582-06e8d962c449 36 fields · synced Oct 8, 2026
- EUDAMED e5aa886d-45a9-4a29-9e18-0bf069591586 61 fields · synced Oct 8, 2026