510(k) K073481

THREVO ANCHOR, DISPOSABLE DRIVER, HI-FI SUTURES by Conmed Linvatec — Product Code MBI

K073481 is an FDA 510(k) premarket notification submitted by Conmed Linvatec for the device "THREVO ANCHOR, DISPOSABLE DRIVER, HI-FI SUTURES". The FDA issued a decision of Substantially Equivalent on January 7, 2008. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), 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
January 7, 2008
Date Received
December 11, 2007
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