510(k) K150468
K150468 is an FDA 510(k) premarket notification submitted by K2 Medical GmbH & Co. KG for the device "Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs". The FDA issued a decision of Substantially Equivalent on February 29, 2016. The device falls under product code HAE (Rongeur, Manual), a Class II device regulated under 21 CFR 882.4840. K2 Medical GmbH & Co. KG has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 29, 2016
- Date Received
- February 23, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Rongeur, Manual
- Device Class
- Class II
- Regulation Number
- 882.4840
- Review Panel
- NE
- Submission Type