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FDA 510(k)

PUMA系統

K 號：K171703 · 2018-03-01

申請人Panther Orthopedics, Inc.
決定日期2018-03-01
產品代碼HTN
諮詢委員會或
決定相當於

器材摘要

PUMA System is the device name listed in this FDA 510(k) record. The listed applicant is Panther Orthopedics, Inc.. It received FDA 510(k) clearance on 2018-03-01 under 510(k) number K171703. The device is classified under product code HTN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PUMA System?

PUMA System is a medical device that received FDA 510(k) clearance on 2018-03-01. The listed applicant is Panther Orthopedics, Inc.. The 510(k) number is K171703.

When did PUMA System receive FDA 510(k) clearance?

PUMA System received FDA 510(k) clearance on 2018-03-01, under 510(k) number K171703.

Who is the listed applicant for PUMA System?

The FDA 510(k) record lists Panther Orthopedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PUMA System?

The FDA product code for PUMA System is HTN.

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官方來源

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