510(k) K173320
K173320 is an FDA 510(k) premarket notification submitted by KLS Martin L.P. for the device "KLS Martin L1 MMF System". The FDA issued a decision of Substantially Equivalent on February 23, 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 at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 23, 2018
- Date Received
- October 20, 2017
- 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