Identity
- Trade Name
- OIC Intramedullary Nail System FDA UDI
- Generic Name
- Medullary canal orthopaedic reamer, flexible FDA UDI
- Device Name
- IM REAMER 14 MM FDA UDI
- Model / Reference
- 01-IM19 FDA UDI
- Description
- IM REAMER 14 MM FDA UDI
Identifiers
- Primary DI / UDI-DI
- M69601IM190 FDA UDI
- 510(k) Number
- K150655 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Medullary canal orthopaedic reamer, flexible FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3020 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 — 14 Millimeter FDA UDI
Category: Medullary canal orthopaedic reamer, flexible
OIC Intramedullary Nail System by Orthopaedic Implant Company, The — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Medullary canal orthopaedic reamer, flexible.
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- Patella Inlay Reamer Size 5 — SIGNATURE ORTHOPAEDICS PTY LTD · Class I
- ARCOS MODULAR REVISION SYSTEM — Biomet Orthopedics, Inc. · Class II
- ARCOS MODULAR REVISION SYSTEM — Biomet Orthopedics, Inc. · Class II
- Arthrex® — Arthrex, Inc. · Class I
- NITINOL MODULAR REAMER HUDSON — Biomet Orthopedics, Inc. · Class I
- Dyna Locking IM Nail — CG MedTech Co., Ltd. · Class I
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Cleared under the same submission
K150655 also covers:
- OIC Intramedullary Nail System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Intramedullary Nail System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Intramedullary Nail System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Intramedullary Nail System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Intramedullary Nail System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Intramedullary Nail System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Intramedullary Nail System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Intramedullary Nail System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Intramedullary Nail System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Intramedullary Nail System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Intramedullary Nail System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Intramedullary Nail System — ORTHOPAEDIC IMPLANT COMPANY, THE
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
- Orthopaedic Implant Company, The
Sources (1)
- FDA UDI d9df7eed-76df-454a-9c76-18a824ecc880 36 fields · synced May 31, 2026