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FDA 510(k)

ABG III MONOLITHIC HIP STEM

K-Number: K123604 · 2013-08-16

ApplicantHowmedica Osteonics Corp.
Decision Date2013-08-16
Product CodeMAY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ABG III MONOLITHIC HIP STEM is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp.. It received FDA 510(k) clearance on 2013-08-16 under 510(k) number K123604. The device is classified under product code MAY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABG III MONOLITHIC HIP STEM?

ABG III MONOLITHIC HIP STEM is a medical device that received FDA 510(k) clearance on 2013-08-16. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K123604.

When did ABG III MONOLITHIC HIP STEM receive FDA 510(k) clearance?

ABG III MONOLITHIC HIP STEM received FDA 510(k) clearance on 2013-08-16, under 510(k) number K123604.

Who is the listed applicant for ABG III MONOLITHIC HIP STEM?

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

What is the FDA product code for ABG III MONOLITHIC HIP STEM?

The FDA product code for ABG III MONOLITHIC HIP STEM is MAY.

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Related Devices (Code: MAY)

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.

K110807ABG II MONOLITHIC HIP STEMStryker Corp.K090103100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3 MAXROM AND +3 HI-WALLBiomet, Inc.K051844EQUATOR PLUS ACETABULAR CUP SYSTEMPortland Orthopaedics Pty. , Ltd.

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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