FDA 510(k)

TRIGEN INTERTAN 10S Nail System

K-번호: K241804 · 2024-08-22

결정일2024-08-22

제품 코드JDS

자문 위원회OR

결정Substantially Equivalent

기기 요약

TRIGEN INTERTAN 10S Nail System is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2024-08-22 under 510(k) number K241804. The device is classified under product code JDS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the TRIGEN INTERTAN 10S Nail System?

TRIGEN INTERTAN 10S Nail System is a medical device that received FDA 510(k) clearance on 2024-08-22. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K241804.

When did TRIGEN INTERTAN 10S Nail System receive FDA 510(k) clearance?

TRIGEN INTERTAN 10S Nail System received FDA 510(k) clearance on 2024-08-22, under 510(k) number K241804.

Who is the listed applicant for TRIGEN INTERTAN 10S Nail System?

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

What is the FDA product code for TRIGEN INTERTAN 10S Nail System?

The FDA product code for TRIGEN INTERTAN 10S Nail System is JDS.

Smith & Nephew, Inc.를 신청인으로 등재한 기타 기록

K261462LANDMARK Total Knee System K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)K254084AETOS 쉼터 시스템 - CONCELOC Glenoids K252416AETOS 쉼터 시스템 Meta Humeral Prosthesis Size 0 K252129AETOS 쉼터 시스템 Stemless Humeral Prosthesis K251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue)

112개 장치 모두 보기 →

공식 출처

FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.