510(k) K133035
K133035 is an FDA 510(k) premarket notification submitted by Normed Medizin-Technik GmbH for the device "NORMED PELLEGRIN CALCANEUS STOP SCREW". The FDA issued a decision of Substantially Equivalent on Dec 13, 2013. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Normed Medizin-Technik GmbH has 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 13, 2013
- Date Received
- Sep 27, 2013
- 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)