510(k) K133770

A.I.M. KNOTLESS MENISCAL REPAIR DEVICE by Anchor Innovation Medical (A.I.M.) — Product Code GAT

K133770 is an FDA 510(k) premarket notification submitted by Anchor Innovation Medical (A.I.M.) for the device "A.I.M. KNOTLESS MENISCAL REPAIR DEVICE". The FDA issued a decision of Substantially Equivalent on June 10, 2014. The device falls under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene), a Class II device regulated under 21 CFR 878.5000. Anchor Innovation Medical (A.I.M.) has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 2014
Date Received
December 11, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class
Class II
Regulation Number
878.5000
Review Panel
SU
Submission Type