MALUC Total Hip Arthroplasty System
K-Number: K162125 · 2017-05-10
ApplicantSurgtech, Inc.
Decision Date2017-05-10
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
MALUC Total Hip Arthroplasty System is a medical device manufactured by Surgtech, Inc.. It received FDA 510(k) clearance on 2017-05-10 under approval number K162125. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the MALUC Total Hip Arthroplasty System?
MALUC Total Hip Arthroplasty System is a medical device that received FDA 510(k) clearance on 2017-05-10. It is manufactured by Surgtech, Inc.. The 510(k) number is K162125.
When was MALUC Total Hip Arthroplasty System approved by the FDA?
MALUC Total Hip Arthroplasty System received FDA 510(k) clearance on 2017-05-10, under approval number K162125.
What company makes MALUC Total Hip Arthroplasty System?
MALUC Total Hip Arthroplasty System is manufactured by Surgtech, Inc..
What is the FDA product code for MALUC Total Hip Arthroplasty System?
The FDA product code for MALUC Total Hip Arthroplasty System is JDI.
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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.