Identity
- Trade Name
- OIC External Fixation System FDA UDI
- Generic Name
- Fluted surgical drill bit, single-use, non-sterile FDA UDI
- Device Name
- 4.0MM X 200MM CALIBRATED DRILL BIT FDA UDI
- Model / Reference
- DR40-200C FDA UDI
- Description
- 4.0MM X 200MM CALIBRATED DRILL BIT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10811998038343 FDA UDI
- 510(k) Number
- K171211 FDA UDI
- FDA Product Code
- KTT FDA UDI
- GMDN Term
- Fluted surgical drill bit, single-use, non-sterile 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
- Length — 200 Millimeter FDA UDIOuter Diameter — 4.0 Millimeter FDA UDI
Category: Fluted surgical drill bit, single-use, non-sterile
OIC External Fixation System by Orthopaedic Implant Company, The — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fluted surgical drill bit, single-use, non-sterile.
- Simpex Drill Bit — SIMPEX MEDICAL, INC. · Class I
- Dynamic Axial Fixator — Orthofix, Inc. · Class II
- Dynamic Axial Fixator — Orthofix, Inc. · Class II
- CURE ACP — MEDITECH SPINE, LLC · Class II
- Simpex Drill Bit — SIMPEX MEDICAL, INC. · Class I
- XtraFix® — Zimmer, Inc. · Class I
- CALIBRATED DRILL BIT — Biomet Orthopedics, Inc. · Class I
- AFT™ Proximal Humerus Fracture Plate System — Shoulder Options, Inc. · Class II
Cleared under the same submission
K171211 also covers:
- OIC External Fixation System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC External Fixation System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC External Fixation System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC External Fixation System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC External Fixation System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC External Fixation System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC External Fixation System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC External Fixation System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC External Fixation System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC External Fixation System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC External Fixation System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC External Fixation 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 e19438d6-4ffc-423d-b70e-f3a604dda0be 36 fields · synced May 30, 2026