Miach Orthopaedics, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Miach Orthopaedics, Inc. - FDA 510(k) Cleared Devices
Recent clearances: BEAR® (Bridge-Enhanced ACL Restoration) Implant, BEAR® (Bridge-Enhanced ACL Restoration) Implant
3
Total
2
Cleared
1
Denied
Miach Orthopaedics, Inc. has 2 FDA 510(k) cleared medical devices. Based in Westborough, US.
Latest FDA clearance: Jan 2026. Active since 2020. Primary specialty: Orthopedic.
Browse the FDA 510(k) cleared devices submitted by Miach Orthopaedics, Inc. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Broderick Regulatory Consulting, LLC as regulatory consultant. 1 device has linked clinical trial registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - Miach Orthopaedics, Inc.
3 devices