FDA 510(k)

Stryker兒童顎骨分離器2

K 號：K181504 · 2018-09-11

決定日期2018-09-11

產品代碼MQN

諮詢委員會DE

決定相當於

器材摘要

Stryker Pediatric Mandibular Distractor 2 is the device name listed in this FDA 510(k) record. The listed applicant is Stryker. It received FDA 510(k) clearance on 2018-09-11 under 510(k) number K181504. The device is classified under product code MQN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Stryker Pediatric Mandibular Distractor 2?

Stryker Pediatric Mandibular Distractor 2 is a medical device that received FDA 510(k) clearance on 2018-09-11. The listed applicant is Stryker. The 510(k) number is K181504.

When did Stryker Pediatric Mandibular Distractor 2 receive FDA 510(k) clearance?

Stryker Pediatric Mandibular Distractor 2 received FDA 510(k) clearance on 2018-09-11, under 510(k) number K181504.

Who is the listed applicant for Stryker Pediatric Mandibular Distractor 2?

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

What is the FDA product code for Stryker Pediatric Mandibular Distractor 2?

The FDA product code for Stryker Pediatric Mandibular Distractor 2 is MQN.

其他以 Stryker 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。

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相關器械（代碼：MQN）

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。

K220050KLS Martin IPS 分離器KLS Martin L.P.K183113DePuy Synthes 頭顎外科產品系列 - MR條件性Synthes (USA) Products, LLC K162594頭顱顎面骨擴張系統 (CMFD)Synthes USA Products, LLC K161470內部干擾 - 無菌KLS Martin L.P.

官方來源

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