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FDA 510(k)

Zimmer M/L Taper Hip Prosthesis

K-Number: K161830 · 2016-10-26

ApplicantZimmer, Inc.
Decision Date2016-10-26
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Zimmer M/L Taper Hip Prosthesis is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 2016-10-26 under 510(k) number K161830. 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 Zimmer M/L Taper Hip Prosthesis?

Zimmer M/L Taper Hip Prosthesis is a medical device that received FDA 510(k) clearance on 2016-10-26. The listed applicant is Zimmer, Inc.. The 510(k) number is K161830.

When did Zimmer M/L Taper Hip Prosthesis receive FDA 510(k) clearance?

Zimmer M/L Taper Hip Prosthesis received FDA 510(k) clearance on 2016-10-26, under 510(k) number K161830.

Who is the listed applicant for Zimmer M/L Taper Hip Prosthesis?

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

What is the FDA product code for Zimmer M/L Taper Hip Prosthesis?

The FDA product code for Zimmer M/L Taper Hip Prosthesis is LZO.

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Other records listing Zimmer, Inc. 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.

PMA P060037Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearingK261683Augment Off-Axis Instrument SystemK260831Z1 Hip SystemK251840Zimmer® Persona® Personalized Knee SystemK260182Avenir® Müller Stem; Avenir Complete™ Hip SystemK253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)

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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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