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FDA 510(k)

BI-MENTUM dual mobility system

K-Number: K181744 · 2018-12-11

ApplicantSerf
Decision Date2018-12-11
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BI-MENTUM dual mobility system is the device name listed in this FDA 510(k) record. The listed applicant is Serf. It received FDA 510(k) clearance on 2018-12-11 under 510(k) number K181744. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BI-MENTUM dual mobility system?

BI-MENTUM dual mobility system is a medical device that received FDA 510(k) clearance on 2018-12-11. The listed applicant is Serf. The 510(k) number is K181744.

When did BI-MENTUM dual mobility system receive FDA 510(k) clearance?

BI-MENTUM dual mobility system received FDA 510(k) clearance on 2018-12-11, under 510(k) number K181744.

Who is the listed applicant for BI-MENTUM dual mobility system?

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

What is the FDA product code for BI-MENTUM dual mobility system?

The FDA product code for BI-MENTUM dual mobility system is LZO.

Other records listing Serf as applicant

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.

K223745Novae® Dual Mobility System, Hype® Hip System

Related Devices (Code: LZO)

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.

K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KGK260831Z1 Hip SystemZimmer, Inc.K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.K260037implantcast Packaging System UpdateImplantcast GmbHK252401implaFit® short stemsImplantcast GmbHK253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, 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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