510(k) K140962
K140962 is an FDA 510(k) premarket notification submitted by Normed Nedizin Technik GmbH for the device "NORMED VARIO SUBTALAR SCREW". The FDA issued a decision of Substantially Equivalent on Jul 3, 2014. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 3, 2014
- Date Received
- Apr 15, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Screw, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type
- 510(k)