510(k) K072291

CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR by Conmed Linvatec — Product Code HWC

K072291 is an FDA 510(k) premarket notification submitted by Conmed Linvatec for the device "CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR". The FDA issued a decision of Substantially Equivalent on July 14, 2008. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Conmed Linvatec has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 2008
Date Received
August 16, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type