510(k) K251214

Device

BEAR® (Bridge-Enhanced ACL Restoration) Implant

Applicant

Miach Orthopaedics, Inc.

510(k) number

K251214

Product code

QNI

Decision

Substantially Equivalent (SESE)

Decision date

2026-01-13

Date received

2025-04-18

Regulation

888.3044

Classification name

Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair

Medical specialty

Orthopedic

Review panel

Orthopedic

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

N