Intraosseous Fixation System
FDA 510(k) K120165 · Orthohelix Surgical Designs, Inc.
510(k) numberK120165
Submission
- Device name
- Intraosseous Fixation System
- Applicant
- Orthohelix Surgical Designs, Inc.
Medina, OH, US - Received
- January 19, 2012
- Decision date
- April 17, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HTY – Pin, Fixation, Smooth
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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More from OSSIO , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K142148 | Orthohelix Staple SystemJDR · Special | 08/21/2014SE |
| K141004 | Intraosseous Fixation SystemHTY · Special | 08/21/2014SE |
| K141301 | Maxlock Extreme Elbow Fracture SystemHRS · Traditional | 07/11/2014SE |
| K132733 | Orthohelix Syndesmosis Fixation DevicesHTN · Traditional | 01/03/2014SE |
| K132591 | Maxlock Extreme SystemHRS · Special | 09/17/2013SE |
| K130832 | Orthohelix Staple SystemJDR · Traditional | 08/15/2013SE |
| K131324 | Maxtorque Screw SystemHWC · Traditional | 05/31/2013SE |
| K123203 | Maxlock Extreme System Model MXLHRS · Traditional | 12/14/2012SE |
| K122005 | Maxlock Extreme SystemHRS · Special | 09/06/2012SE |
| K121437 | Mini Maxlock Extreme Plating SystemHRS · Special | 06/13/2012SE |
Questions and answers
When was Intraosseous Fixation System cleared by the FDA?
Intraosseous Fixation System (K120165) received a 510(k) decision of Substantially Equivalent on April 17, 2012, 89 days after the submission was received.
What is the product code of K120165?
The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.