FDA 510(k)

精密脊椎間板系統

K 號：K160568 · 2016-05-04

決定日期2016-05-04

產品代碼PEK

諮詢委員會或

決定相當於

器材摘要

Precision Spine Interspinous Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Precision Spine, Inc.. It received FDA 510(k) clearance on 2016-05-04 under 510(k) number K160568. The device is classified under product code PEK. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Precision Spine Interspinous Plate System?

Precision Spine Interspinous Plate System is a medical device that received FDA 510(k) clearance on 2016-05-04. The listed applicant is Precision Spine, Inc.. The 510(k) number is K160568.

When did Precision Spine Interspinous Plate System receive FDA 510(k) clearance?

Precision Spine Interspinous Plate System received FDA 510(k) clearance on 2016-05-04, under 510(k) number K160568.

Who is the listed applicant for Precision Spine Interspinous Plate System?

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

What is the FDA product code for Precision Spine Interspinous Plate System?

The FDA product code for Precision Spine Interspinous Plate System is PEK.

其他以 Precision Spine, Inc. 為申請人之記錄

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相關器械（代碼：PEK）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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