All Poly Tibial Component

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

UNITED ORTHOPEDIC CORPORATION

The following data is part of a premarket notification filed by United Orthopedic Corporation with the FDA for All Poly Tibial Component.

Pre-market Notification Details

• Device ID: K152430
• 510k Number: K152430
• Device Name: All Poly Tibial Component
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: UNITED ORTHOPEDIC CORPORATION NO 57, PARK AVE 2, SCIENCE PARK Hsinchu, TW 300
• Contact: Karen Ho
• Correspondent: Karen Ho; UNITED ORTHOPEDIC CORPORATION NO 57, PARK AVE 2, SCIENCE PARK Hsinchu, TW 300
• Product Code: JWH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-08-26
• Decision Date: 2016-04-12
• Summary: summary

NIH GUDID Devices

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