Device Classification Name |
fastener, fixation, nondegradable, soft tissue
|
510(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) |
169 E Reynolds Road, Suite 203B |
Lexington,
KY
40517
|
|
Applicant Contact |
Jeremy Jarmon |
Correspondent |
Rogers Consulting |
11110 Arranmore Cove |
Roanoke,
IN
46783
|
|
Correspondent Contact |
W. Victoria Rogers |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 02/27/2023 |
Decision Date | 09/11/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|