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FDA 510(k)

PROCOTYL® PRIME E-CLASS™ XLPE Liner

K-Number: K171181 · 2017-08-28

ApplicantMicroport Orthopedics, Inc.
Decision Date2017-08-28
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PROCOTYL® 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 2017-08-28 under 510(k) number K171181. 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 PROCOTYL® PRIME E-CLASS™ XLPE Liner?

PROCOTYL® PRIME E-CLASS™ XLPE Liner is a medical device that received FDA 510(k) clearance on 2017-08-28. The listed applicant is Microport Orthopedics, Inc.. The 510(k) number is K171181.

When did PROCOTYL® PRIME E-CLASS™ XLPE Liner receive FDA 510(k) clearance?

PROCOTYL® PRIME E-CLASS™ XLPE Liner received FDA 510(k) clearance on 2017-08-28, under 510(k) number K171181.

Who is the listed applicant for PROCOTYL® 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 PROCOTYL® PRIME E-CLASS™ XLPE Liner?

The FDA product code for PROCOTYL® 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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