510(k) K052572

ANSPACH KNOTLESS ANCHOR by The Anspach Effort, Inc. — Product Code MBI

K052572 is an FDA 510(k) premarket notification submitted by The Anspach Effort, Inc. for the device "ANSPACH KNOTLESS ANCHOR". The FDA issued a decision of Substantially Equivalent on December 5, 2005. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. The Anspach Effort, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 2005
Date Received
September 19, 2005
Clearance Type
Traditional
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