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FDA 510(k)

BEAR® (Bridge-Enhanced ACL Restoration) Implant

K-Number: K243578 · 2025-03-06

ApplicantMiach Orthopaedics, Inc.
Decision Date2025-03-06
Product CodeQNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BEAR® (Bridge-Enhanced ACL Restoration) Implant is a medical device manufactured by Miach Orthopaedics, Inc.. It received FDA 510(k) clearance on 2025-03-06 under approval number K243578. The device is classified under product code QNI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BEAR® (Bridge-Enhanced ACL Restoration) Implant?

BEAR® (Bridge-Enhanced ACL Restoration) Implant is a medical device that received FDA 510(k) clearance on 2025-03-06. It is manufactured by Miach Orthopaedics, Inc.. The 510(k) number is K243578.

When was BEAR® (Bridge-Enhanced ACL Restoration) Implant approved by the FDA?

BEAR® (Bridge-Enhanced ACL Restoration) Implant received FDA 510(k) clearance on 2025-03-06, under approval number K243578.

What company makes BEAR® (Bridge-Enhanced ACL Restoration) Implant?

BEAR® (Bridge-Enhanced ACL Restoration) Implant is manufactured by Miach Orthopaedics, Inc..

What is the FDA product code for BEAR® (Bridge-Enhanced ACL Restoration) Implant?

The FDA product code for BEAR® (Bridge-Enhanced ACL Restoration) Implant is QNI.

Related Clinical Trials

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Other Devices by Miach Orthopaedics, Inc.

DEN200035BEAR (Bridge-Enhanced ACL Repair) Implant K251214BEAR® (Bridge-Enhanced ACL Restoration) Implant

Related Devices (Code: QNI)

DEN200035BEAR (Bridge-Enhanced ACL Repair) ImplantMiach Orthopaedics, Inc. K251214BEAR® (Bridge-Enhanced ACL Restoration) ImplantMiach Orthopaedics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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