PROCOTYL® PRIME E-CLASS™ XLPE Liner

Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

MicroPort Orthopedics, Inc.

The following data is part of a premarket notification filed by Microport Orthopedics, Inc. with the FDA for Procotyl® Prime E-class™ Xlpe Liner.

Pre-market Notification Details

• Device ID: K171181
• 510k Number: K171181
• Device Name: PROCOTYL® PRIME E-CLASS™ XLPE Liner
• Classification: Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
• Applicant: MicroPort Orthopedics, Inc. 5677 Airline Road Arlington, TN 38002
• Contact: Sarah Evonne Stroupe
• Correspondent: Sarah Evonne Stroupe; MicroPort Orthopedics, Inc. 5677 Airline Road Arlington, TN 38002
• Product Code: LZO
• Subsequent Product Code: LPH
• Subsequent Product Code: OQG
• Subsequent Product Code: OQI
• CFR Regulation Number: 888.3353 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-04-24
• Decision Date: 2017-08-28