510(k) K122208
K122208 is an FDA 510(k) premarket notification submitted by Christopher D. Endara for the device "EXTERNAL FIXATOR SYSTEM". The FDA issued a decision of Substantially Equivalent on December 20, 2012. The device falls under product code NDK (System, External Fixator (With Metallic Invasive Components)), a Class II device regulated under 21 CFR 888.3040.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 20, 2012
- Date Received
- July 25, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, External Fixator (With Metallic Invasive Components)
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type