FDA 510(k)

KLS Martin LSS 鍍層系統

K 號：K151983 · 2016-04-06

決定日期2016-04-06

產品代碼JDQ

諮詢委員會或

決定相當於

器材摘要

KLS Martin LSS Plating System is the device name listed in this FDA 510(k) record. The listed applicant is KLS Martin L.P.. It received FDA 510(k) clearance on 2016-04-06 under 510(k) number K151983. The device is classified under product code JDQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the KLS Martin LSS Plating System?

KLS Martin LSS Plating System is a medical device that received FDA 510(k) clearance on 2016-04-06. The listed applicant is KLS Martin L.P.. The 510(k) number is K151983.

When did KLS Martin LSS Plating System receive FDA 510(k) clearance?

KLS Martin LSS Plating System received FDA 510(k) clearance on 2016-04-06, under 510(k) number K151983.

Who is the listed applicant for KLS Martin LSS Plating System?

The FDA 510(k) record lists KLS Martin L.P. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KLS Martin LSS Plating System?

The FDA product code for KLS Martin LSS Plating System is JDQ.

其他以 KLS Martin L.P. 為申請人之記錄

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。

K260137KLS Martin IPS 口腔-馬克斯植入物 - MR條件性；個人患者解決方案 - Ti (IPS-Ti)；個人患者解決方案 - PEEK (IPS-PEEK)；KLS Martin 個人患者解決方案 K254162KLS Martin Ixos 系統 K253660KLS Martin 純淨胸骨系統 K250988KLS Martin 純淨胸骨系統 K250865KLS Martin IPS 臂部系統 K252573KLS Martin 頭蓋內植物 - MR條件性；K944565：KLS-Martin 微骨固定系統（1.5MM）；K971297：KLS Martin 中心驅動無釘螺釘；K060177：KLS Martin 嚴格固定 - 無菌；K062570：個人化病人解決方案 - Ti（IPS-Ti）；K072707：個人化病人解決方案 - PEEK（IPS-PEEK）；K151382：個人化病人解決方案 - （IPS-PEEK）- 無菌

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相關器械（代碼：JDQ）

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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