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View Plating System, Reduce Fracture Plating System
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM FDA UDI
- Generic Name
- Surgical countersink, single-use FDA UDI
- Device Name
- CUP REAMER, 16MM, QUICK CONNECT FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- CUP REAMER, 16MM, QUICK CONNECT FDA UDI
Identifiers
- Catalog Number
- 002-A-16010 FDA UDI
- Primary DI / UDI-DI
- 18056099648202 FDA UDI
- 510(k) Number
- K142135 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Surgical countersink, 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 16 Millimeter FDA UDI
Category: Surgical countersink, single-use
View Plating System, Reduce Fracture Plating System by Orthofix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical countersink, single-use.
- Volition Plating System — ORTHO SOLUTIONS HOLDINGS LIMITED · Class I
- GEO Bone Screw System — GRAMERCY EXTREMITY ORTHOPEDICS, LLC. · Class I
- ORTHO SOLUTIONS STERILE DRILL BITS — ORTHO SOLUTIONS HOLDINGS LIMITED · Class I
- CrossRoads Screw System — CROSSROADS EXTREMITY SYSTEMS LLC · Class I
- FuzeFix Mini — FUSION ORTHOPEDICS, LLC · Class II
- Healix — NVISION BIOMEDICAL TECHNOLOGIES, INC · Class I
- Dyna Locking Cannulated Screw — CG MedTech Co., Ltd. · Class I
- PolyLock Midfoot — FUSION ORTHOPEDICS, LLC · Class II
Cleared under the same submission
K142135 also covers:
- RIVAL VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM — Orthofix, Inc.
- RIVAL VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM — Orthofix, Inc.
- RIVAL VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM — Orthofix, Inc.
- RIVAL VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM — Orthofix, Inc.
- RIVAL VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM — Orthofix, Inc.
- RIVAL VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM — Orthofix, Inc.
- RIVAL VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM — Orthofix, Inc.
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM — Orthofix, Inc.
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM — Orthofix, Inc.
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM — Orthofix, Inc.
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM — Orthofix, Inc.
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM — Orthofix, Inc.
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
- Orthofix, Inc.
Sources (1)
- FDA UDI a02eb5c9-9f0a-42d4-b499-9a1a0ef439da 37 fields · synced May 30, 2026