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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 the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2019-01-22 under 510(k) 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. The listed applicant is Biomet, Inc.. The 510(k) number is K183553.

When did Compress and Mini Compress Anti-Rotation Spindles receive FDA 510(k) clearance?

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

Who is the listed applicant for Compress and Mini Compress Anti-Rotation Spindles?

The FDA 510(k) record lists Biomet, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Biomet, Inc. as applicant

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Related Devices (Code: MBF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)Zimmer, Inc.K251098Identity Revision Humeral StemsZimmer, Inc.K250848Identity Shoulder SystemZimmer, Inc.K240876Identity Shoulder SystemZimmer, Inc.K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.

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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