510(k) K180962
K180962 is an FDA 510(k) premarket notification submitted by KLS-Martin L.P. for the device "KLS Martin Individual Patient Solutions". The FDA issued a decision of Substantially Equivalent on Aug 13, 2018. The device falls under product code JEY (Plate, Bone), a Class II device regulated under 21 CFR 872.4760. KLS-Martin L.P. has 58 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 13, 2018
- Date Received
- Apr 12, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Bone
- Device Class
- Class II
- Regulation Number
- 872.4760
- Review Panel
- DE
- Submission Type
- 510(k)