FDA 510(k) Premarket Notification K141345: AEQUALIS FX2

Submission Details & Decision

Normalized public record details for 510(k) notification K141345.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K141345

Applicant / Sponsor

Tornier S.A.S.

Device Name

AEQUALIS FX2

Product Code

PHX

Decision Date

2014-11-18

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Orthopedic (OR)

Clearance Type

Traditional

Third Party Flag

Date Received

2014-05-22

Related Establishments / Registrations

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