Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Latitud Hip Replacement System

K-Number: K183532 · 2019-07-18

Decision Date2019-07-18
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Latitud Hip Replacement System is the device name listed in this FDA 510(k) record. The listed applicant is Meril Healthcare Pvt. , Ltd.. It received FDA 510(k) clearance on 2019-07-18 under 510(k) number K183532. 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 Latitud Hip Replacement System?

Latitud Hip Replacement System is a medical device that received FDA 510(k) clearance on 2019-07-18. The listed applicant is Meril Healthcare Pvt. , Ltd.. The 510(k) number is K183532.

When did Latitud Hip Replacement System receive FDA 510(k) clearance?

Latitud Hip Replacement System received FDA 510(k) clearance on 2019-07-18, under 510(k) number K183532.

Who is the listed applicant for Latitud Hip Replacement System?

The FDA 510(k) record lists Meril Healthcare Pvt. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Latitud Hip Replacement System?

The FDA product code for Latitud Hip Replacement System is LZO.

Other records listing Meril Healthcare Pvt. , Ltd. as applicant

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.

View all 7 devices →

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.

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.