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

FDA 510(k)

ASK System

K-Number: K181146 · 2018-08-03

ApplicantL and K Biomed Corporation Limited
Decision Date2018-08-03
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ASK System is a medical device manufactured by L and K Biomed Corporation Limited. It received FDA 510(k) clearance on 2018-08-03 under approval number K181146. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASK System?

ASK System is a medical device that received FDA 510(k) clearance on 2018-08-03. It is manufactured by L and K Biomed Corporation Limited. The 510(k) number is K181146.

When was ASK System approved by the FDA?

ASK System received FDA 510(k) clearance on 2018-08-03, under approval number K181146.

What company makes ASK System?

ASK System is manufactured by L and K Biomed Corporation Limited.

What is the FDA product code for ASK System?

The FDA product code for ASK System is JWH.

Related Devices (Code: JWH)

K160515PS2 Knee SystemConsensus Orthopedics, Inc. K160771Destiknee Total Knee SystemMeril Healthcare Private Limited K160157LOSPA Modular Knee SystemCorentec Co., Ltd. K162273Materialise TKA Guide SystemMaterialise NV K162422Klassic Knee SystemTotal Joint Orthopedics, Inc. K161945EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm)Encore Medical L.P.

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.

↑