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)— 510(k) K230517
Substantially EquivalentJarmon Medical, LLC (Dba Legends Orthopedics)
FDA 510(k) clearance K230517 for 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), Substantially Equivalent on 2023-09-11. Applicant: Jarmon Medical, LLC (Dba Legends Orthopedics).
Clearance details
- Applicant
- Jarmon Medical, LLC (Dba Legends Orthopedics)
- Product code
- Code MBI
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lexington, KY, US
Adverse events under product code MBI
product code MBI- Injury
- 3,163
- Malfunction
- 13,006
- Other
- 2
- Total
- 16,171
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.