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Ortho Solutions Extremity Fixation Implants for Osteosysnthesis
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Ortho Solutions Extremity Fixation Implants for Osteosysnthesis FDA UDI
- Generic Name
- Cannulated surgical drill bit, single-use FDA UDI
- Device Name
- AO QC COMPRESSION SCREW DRILL 18MM FDA UDI
- Model / Reference
- OS310203 FDA UDI
- Description
- AO QC COMPRESSION SCREW DRILL 18MM FDA UDI
Identifiers
- Catalog Number
- OS310203 FDA UDI
- Primary DI / UDI-DI
- 05055662932706 FDA UDI
- 510(k) Number
- K111678 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Cannulated surgical drill bit, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cannulated surgical drill bit, single-use
Ortho Solutions Extremity Fixation Implants for Osteosysnthesis by Ortho Solutions Holdings Limited — Class II — FDA UDI — listed in FDA GUDID
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Cleared under the same submission
K111678 also covers:
- ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS — ORTHO SOLUTIONS HOLDINGS LIMITED
- ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS — ORTHO SOLUTIONS HOLDINGS LIMITED
- ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS — ORTHO SOLUTIONS HOLDINGS LIMITED
- ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS — ORTHO SOLUTIONS HOLDINGS LIMITED
- ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS — ORTHO SOLUTIONS HOLDINGS LIMITED
- ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS — ORTHO SOLUTIONS HOLDINGS LIMITED
- ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS — ORTHO SOLUTIONS HOLDINGS LIMITED
- ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS — ORTHO SOLUTIONS HOLDINGS LIMITED
- ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS — ORTHO SOLUTIONS HOLDINGS LIMITED
- ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS — ORTHO SOLUTIONS HOLDINGS LIMITED
- ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS — ORTHO SOLUTIONS HOLDINGS LIMITED
- ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS — ORTHO SOLUTIONS HOLDINGS LIMITED
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
- Ortho Solutions Holdings Limited
Sources (1)
- FDA UDI efbe7132-00c5-4407-8602-9842b8f51711 35 fields · synced May 30, 2026