BEAR® (Bridge-Enhanced ACL Restoration) Implant— 510(k) K251214

Substantially Equivalent

Miach Orthopaedics, Inc.

FDA 510(k) clearance K251214 for BEAR® (Bridge-Enhanced ACL Restoration) Implant, Substantially Equivalent on 2026-01-13. Applicant: Miach Orthopaedics, Inc..

Clearance details

Applicant: Miach Orthopaedics, Inc.
Product code: Code QNI
Advisory panel: Orthopedic
Date received: 2025-04-18
Decision date: 2026-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westborough, MA, US

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