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FDA 510(k)

Ball Joint Guide Array (66295)

K-Number: K250893 · 2025-09-04

ApplicantBayer Medical Care, Inc.
Decision Date2025-09-04
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Ball Joint Guide Array (66295) is a medical device manufactured by Bayer Medical Care, Inc.. It received FDA 510(k) clearance on 2025-09-04 under approval number K250893. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ball Joint Guide Array (66295)?

Ball Joint Guide Array (66295) is a medical device that received FDA 510(k) clearance on 2025-09-04. It is manufactured by Bayer Medical Care, Inc.. The 510(k) number is K250893.

When was Ball Joint Guide Array (66295) approved by the FDA?

Ball Joint Guide Array (66295) received FDA 510(k) clearance on 2025-09-04, under approval number K250893.

What company makes Ball Joint Guide Array (66295)?

Ball Joint Guide Array (66295) is manufactured by Bayer Medical Care, Inc..

What is the FDA product code for Ball Joint Guide Array (66295)?

The FDA product code for Ball Joint Guide Array (66295) is HAW.

Related Clinical Trials

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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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