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FDA 510(k)

IONGUARD TITANIUM MODULAR HEADS

K-Number: K915548 · 1992-03-10

ApplicantBiomet, Inc.
Decision Date1992-03-10
Product CodeLZY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

IONGUARD TITANIUM MODULAR HEADS is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 1992-03-10 under 510(k) number K915548. The device is classified under product code LZY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IONGUARD TITANIUM MODULAR HEADS?

IONGUARD TITANIUM MODULAR HEADS is a medical device that received FDA 510(k) clearance on 1992-03-10. The listed applicant is Biomet, Inc.. The 510(k) number is K915548.

When did IONGUARD TITANIUM MODULAR HEADS receive FDA 510(k) clearance?

IONGUARD TITANIUM MODULAR HEADS received FDA 510(k) clearance on 1992-03-10, under 510(k) number K915548.

Who is the listed applicant for IONGUARD TITANIUM MODULAR HEADS?

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 IONGUARD TITANIUM MODULAR HEADS?

The FDA product code for IONGUARD TITANIUM MODULAR HEADS is LZY.

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Related Devices (Code: LZY)

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.

K231448TANDEM Hip SystemSmith & Nephew, Inc.K111145ENDO HEADMedacta InternationalK974442PRE-POWDERED NITRILE EXAMINATION GLOVESP.T. Latexindo TobaperkasaK915528BHR BIPOLAR FEMORAL HEAD COMPONENTImplantology Corp.K903084MODULAR CATHCART FRACTURE SYSTEMDepuy, Inc.K896580UNI-POLAR HEADRichards Medical Co., 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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