510(k) K060177

KLS MARTIN RIGID FIXATION - STERILE by KLS Martin L.P. — Product Code JEY

K060177 is an FDA 510(k) premarket notification submitted by KLS Martin L.P. for the device "KLS MARTIN RIGID FIXATION - STERILE". The FDA issued a decision of Substantially Equivalent on April 18, 2006. 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
April 18, 2006
Date Received
January 23, 2006
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