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)
FDA 510(k) clearance K230517 · decided 2023-09-11
Clearance details
- K-number
- K230517
- Device name
- 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)
- Applicant
- Jarmon Medical, LLC (Dba Legends Orthopedics)
- Decision
- Substantially Equivalent
- Date received
- 2023-02-27
- Decision date
- 2023-09-11
- Days to decision
- 196 days
- Clearance type
- Traditional
- Product code
- MBI
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Lexington, KY, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Jarmon Medical
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.