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FDA 510(k)

Prime E-CLASS XLPE Liner

K-Number: K181598 · 2018-09-14

ApplicantMicroport Orthopedics, Inc.
Decision Date2018-09-14
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Prime E-CLASS XLPE Liner is the device name listed in this FDA 510(k) record. The listed applicant is Microport Orthopedics, Inc.. It received FDA 510(k) clearance on 2018-09-14 under 510(k) number K181598. 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 Prime E-CLASS XLPE Liner?

Prime E-CLASS XLPE Liner is a medical device that received FDA 510(k) clearance on 2018-09-14. The listed applicant is Microport Orthopedics, Inc.. The 510(k) number is K181598.

When did Prime E-CLASS XLPE Liner receive FDA 510(k) clearance?

Prime E-CLASS XLPE Liner received FDA 510(k) clearance on 2018-09-14, under 510(k) number K181598.

Who is the listed applicant for Prime E-CLASS XLPE Liner?

The FDA 510(k) record lists Microport Orthopedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Prime E-CLASS XLPE Liner?

The FDA product code for Prime E-CLASS XLPE Liner is LZO.

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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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