510(k) K241219

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

December 11, 2024

Date Received

May 1, 2024

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon

Device Class

Class II

Regulation Number

878.3300

Review Panel

OR

Submission Type

For reinforcement of soft tissue where weakness exists in tendon repair.