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FDA 510(k)

Compress and Mini Compress Anti-Rotation Spindles

K-Number: K183553 · 2019-01-22

ApplicantBiomet, Inc.
Decision Date2019-01-22
Product CodeMBF
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Compress and Mini Compress Anti-Rotation Spindles is a medical device manufactured by Biomet, Inc.. It received FDA 510(k) clearance on 2019-01-22 under approval number K183553. The device is classified under product code MBF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Compress and Mini Compress Anti-Rotation Spindles?

Compress and Mini Compress Anti-Rotation Spindles is a medical device that received FDA 510(k) clearance on 2019-01-22. It is manufactured by Biomet, Inc.. The 510(k) number is K183553.

When was Compress and Mini Compress Anti-Rotation Spindles approved by the FDA?

Compress and Mini Compress Anti-Rotation Spindles received FDA 510(k) clearance on 2019-01-22, under approval number K183553.

What company makes Compress and Mini Compress Anti-Rotation Spindles?

Compress and Mini Compress Anti-Rotation Spindles is manufactured by Biomet, Inc..

What is the FDA product code for Compress and Mini Compress Anti-Rotation Spindles?

The FDA product code for Compress and Mini Compress Anti-Rotation Spindles is MBF.

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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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