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FDA 510(k)

BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System

K-Number: K192416 · 2019-10-01

ApplicantZimmer GmbH
Decision Date2019-10-01
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer GmbH. It received FDA 510(k) clearance on 2019-10-01 under 510(k) number K192416. 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 BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System?

BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System is a medical device that received FDA 510(k) clearance on 2019-10-01. The listed applicant is Zimmer GmbH. The 510(k) number is K192416.

When did BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System receive FDA 510(k) clearance?

BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System received FDA 510(k) clearance on 2019-10-01, under 510(k) number K192416.

Who is the listed applicant for BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System?

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

What is the FDA product code for BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System?

The FDA product code for BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System is LZO.

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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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