510(k) K152256
K152256 is an FDA 510(k) premarket notification submitted by Normed Medizin-Technik GmbH for the device "RECON system- Grubber Lapidus-, Platar Lapidus-, Tarsalis Plates and Screws". The FDA issued a decision of Substantially Equivalent on Nov 5, 2015. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Normed Medizin-Technik GmbH has 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 5, 2015
- Date Received
- Aug 10, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type
- 510(k)