510(k) K142418
K142418 is an FDA 510(k) premarket notification submitted by I.T.S. GmbH for the device "I.T.S. Hand Locking Plates System - HLS". The FDA issued a decision of Substantially Equivalent on September 26, 2014. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. I.T.S. GmbH has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 26, 2014
- Date Received
- August 28, 2014
- 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