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Ortho Solutions Extremity Fixation Implants For Osteosysnthesis
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS FDA UDI
- Generic Name
- Surgical countersink, single-use FDA UDI
- Device Name
- EFS COUNTERSINK FOR 2.0/2.4/3.0MM SCREWS FDA UDI
- Model / Reference
- OS305107 FDA UDI
- Description
- EFS COUNTERSINK FOR 2.0/2.4/3.0MM SCREWS FDA UDI
Identifiers
- Catalog Number
- OS305107 FDA UDI
- Primary DI / UDI-DI
- 05055662962444 FDA UDI
- 510(k) Number
- K111678 FDA UDI
- FDA Product Code
- HWE FDA UDI
- GMDN Term
- Surgical countersink, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4820 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: Surgical countersink, single-use
Ortho Solutions Extremity Fixation Implants For Osteosysnthesis by Ortho Solutions Holdings Limited — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Surgical countersink, single-use.
- GEO Bone Screw System — GRAMERCY EXTREMITY ORTHOPEDICS, LLC. · Class I
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM — Orthofix, Inc. · Class II
- CrossRoads Screw System — CROSSROADS EXTREMITY SYSTEMS LLC · Class I
- BITE COMPRESSION SCREWS — Orthofix, Inc. · Class II
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM — Orthofix, Inc. · Class II
- FuzeFix Mini — FUSION ORTHOPEDICS, LLC · Class II
- Healix — NVISION BIOMEDICAL TECHNOLOGIES, INC · Class I
- Dyna Locking Cannulated Screw — CG MedTech Co., Ltd. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Ortho Solutions Holdings Limited
Sources (1)
- FDA UDI e2f024bf-3c21-4c00-80fc-082de36a2570 36 fields · synced May 30, 2026