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FDA 510(k)

2GC HIP/KNEE MODULAR SPACER

K-Number: K112470 · 2012-04-05

ApplicantMandell Horwitz Consultants, LLC
Decision Date2012-04-05
Product CodeKWL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

2GC HIP/KNEE MODULAR SPACER is the device name listed in this FDA 510(k) record. The listed applicant is Mandell Horwitz Consultants, LLC. It received FDA 510(k) clearance on 2012-04-05 under 510(k) number K112470. The device is classified under product code KWL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 2GC HIP/KNEE MODULAR SPACER?

2GC HIP/KNEE MODULAR SPACER is a medical device that received FDA 510(k) clearance on 2012-04-05. The listed applicant is Mandell Horwitz Consultants, LLC. The 510(k) number is K112470.

When did 2GC HIP/KNEE MODULAR SPACER receive FDA 510(k) clearance?

2GC HIP/KNEE MODULAR SPACER received FDA 510(k) clearance on 2012-04-05, under 510(k) number K112470.

Who is the listed applicant for 2GC HIP/KNEE MODULAR SPACER?

The FDA 510(k) record lists Mandell Horwitz Consultants, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 2GC HIP/KNEE MODULAR SPACER?

The FDA product code for 2GC HIP/KNEE MODULAR SPACER is KWL.

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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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