510(k) K230517

Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends Orthopedics 2.9 mm Suture Anchor, and Legends Orthopedics 5.5 mm Knotless Suture Anchor) by Jarmon Medical, LLC (Dba Legends Orthopedics) — Product Code MBI

K230517 is an FDA 510(k) premarket notification submitted by Jarmon Medical, LLC (Dba Legends Orthopedics) for the device "Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends Orthopedics 2.9 mm Suture Anchor, and Legends Orthopedics 5.5 mm Knotless Suture Anchor)". The FDA issued a decision of Substantially Equivalent on September 11, 2023. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 2023
Date Received
February 27, 2023
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