FDA 510(k) Premarket Notification K201660: KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System

Submission Details & Decision

Normalized public record details for 510(k) notification K201660.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K201660

Applicant / Sponsor

Kyocera Medical Technologies, Inc.

Device Name

KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System

Product Code

OQG

Decision Date

2020-07-16

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Orthopedic (OR)

Clearance Type

Special

Third Party Flag

Date Received

2020-06-18

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