FDA 510(k)

VSTAAR調節器

K 號：K160278 · 2016-11-04

決定日期2016-11-04

產品代碼LXM

決定相當於

器材摘要

VSTAAR AdjusteR is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Acoustics, LLC. It received FDA 510(k) clearance on 2016-11-04 under 510(k) number K160278. The device is classified under product code LXM. FDA Decision: Substantially Equivalent.

常見問題

What is the VSTAAR AdjusteR?

VSTAAR AdjusteR is a medical device that received FDA 510(k) clearance on 2016-11-04. The listed applicant is Spinal Acoustics, LLC. The 510(k) number is K160278.

When did VSTAAR AdjusteR receive FDA 510(k) clearance?

VSTAAR AdjusteR received FDA 510(k) clearance on 2016-11-04, under 510(k) number K160278.

Who is the listed applicant for VSTAAR AdjusteR?

The FDA 510(k) record lists Spinal Acoustics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VSTAAR AdjusteR?

The FDA product code for VSTAAR AdjusteR is LXM.

相關器械（代碼：LXM）

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。

K234036SONIK MONARK 100Neuro Spinal Innovation, Inc.K192629脊椎分析器Optima Health Solutions International Corp.K172536Atlas 擊擊調整儀器Spinalight, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。

器材摘要

常見問題

相關臨床試驗

相關器械（代碼：LXM）

官方來源