FDA 510(k)

AETOS 쉼터 시스템 Stemless Humeral Prosthesis

K-번호: K240716 · 2024-11-20

결정일2024-11-20

제품 코드PKC

자문 위원회OR

결정Substantially Equivalent

기기 요약

AETOS Shoulder System Stemless Humeral Prosthesis 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 2024-11-20 under 510(k) number K240716. The device is classified under product code PKC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the AETOS Shoulder System Stemless Humeral Prosthesis?

AETOS Shoulder System Stemless Humeral Prosthesis is a medical device that received FDA 510(k) clearance on 2024-11-20. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K240716.

When did AETOS Shoulder System Stemless Humeral Prosthesis receive FDA 510(k) clearance?

AETOS Shoulder System Stemless Humeral Prosthesis received FDA 510(k) clearance on 2024-11-20, under 510(k) number K240716.

Who is the listed applicant for AETOS Shoulder System Stemless Humeral Prosthesis?

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 AETOS Shoulder System Stemless Humeral Prosthesis?

The FDA product code for AETOS Shoulder System Stemless Humeral Prosthesis is PKC.

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)

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