FDA 510(k)

鎖定兒童骨切板系統（LolliPOP）

K 號：K170704 · 2017-09-08

決定日期2017-09-08

產品代碼KTT

諮詢委員會或

決定相當於

器材摘要

The Locking Pediatric Osteotomy Plate (LolliPOP) System is the device name listed in this FDA 510(k) record. The listed applicant is Pega Medical, Inc.. It received FDA 510(k) clearance on 2017-09-08 under 510(k) number K170704. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the The Locking Pediatric Osteotomy Plate (LolliPOP) System?

The Locking Pediatric Osteotomy Plate (LolliPOP) System is a medical device that received FDA 510(k) clearance on 2017-09-08. The listed applicant is Pega Medical, Inc.. The 510(k) number is K170704.

When did The Locking Pediatric Osteotomy Plate (LolliPOP) System receive FDA 510(k) clearance?

The Locking Pediatric Osteotomy Plate (LolliPOP) System received FDA 510(k) clearance on 2017-09-08, under 510(k) number K170704.

Who is the listed applicant for The Locking Pediatric Osteotomy Plate (LolliPOP) System?

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

What is the FDA product code for The Locking Pediatric Osteotomy Plate (LolliPOP) System?

The FDA product code for The Locking Pediatric Osteotomy Plate (LolliPOP) System is KTT.

其他以 Pega Medical, Inc. 為申請人之記錄

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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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