510(k) K140127

FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP by Pontis Orthopaedics, LLC — Product Code GAQ

K140127 is an FDA 510(k) premarket notification submitted by Pontis Orthopaedics, LLC for the device "FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP". The FDA issued a decision of Substantially Equivalent on May 28, 2014. The device falls under product code GAQ (Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile), a Class II device regulated under 21 CFR 878.4495. Pontis Orthopaedics, LLC has at least 1 other 510(k) clearance on record.