510(k) K181120

2.8 mm/3.3 mm PopLok Suture Anchors by Conmed Corporation — Product Code MBI

K181120 is an FDA 510(k) premarket notification submitted by Conmed Corporation for the device "2.8 mm/3.3 mm PopLok Suture Anchors". The FDA issued a decision of Substantially Equivalent on Dec 21, 2018. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Conmed Corporation has 82 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Dec 21, 2018
Date Received
Apr 27, 2018
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type
510(k)