FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OIC External Fixation System
K Number: K171211
·
Decision Sep 27, 2017
Classifications
1
FEI Numbers
247
Registration Numbers
247
Same Product Code
392
Applicant Total
8
Review Days
155
Basic Information
- Device Name
- OIC External Fixation System
- K Number
- K171211
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Orthopaedic Implant Company
- Date Received
- April 25, 2017
- Decision Date
- September 27, 2017
- Product Code
- KTT
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | FDA class 2 | Orthopedic |
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Other Clearances by Orthopaedic Implant Company
| K Number | Device Name | ||
|---|---|---|---|
| K233531 | OIC FLEX-FIX System | Feb 2, 2024 | Substantially Equivalent |
| K223761 | OIC Intramedullary Screw System | Feb 13, 2023 | Substantially Equivalent |
| K223118 | OIC Variable Angle Small Fragment Locking Plate System | Jan 21, 2023 | Substantially Equivalent |
| K212601 | DRPx Locking Distal Radius Plate System | Apr 5, 2022 | Substantially Equivalent |
| K202971 | DRPx Locking Distal Radius Plate System | May 6, 2021 | Substantially Equivalent |
| K211112 | OIC External Fixation System | May 5, 2021 | Substantially Equivalent |
| K183682 | OIC External Fixation System | Apr 8, 2019 | Substantially Equivalent |