FDA 510(k)

VLP Wrist Fracture System

K-번호: K161665 · 2016-11-15

결정일2016-11-15

제품 코드HRS

자문 위원회OR

결정Substantially Equivalent

기기 요약

VLP Wrist Fracture 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 2016-11-15 under 510(k) number K161665. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the VLP Wrist Fracture System?

VLP Wrist Fracture System is a medical device that received FDA 510(k) clearance on 2016-11-15. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K161665.

When did VLP Wrist Fracture System receive FDA 510(k) clearance?

VLP Wrist Fracture System received FDA 510(k) clearance on 2016-11-15, under 510(k) number K161665.

Who is the listed applicant for VLP Wrist Fracture 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 VLP Wrist Fracture System?

The FDA product code for VLP Wrist Fracture System is HRS.

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 Shoulder System - CONCELOC Glenoids K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0 K252129AETOS Shoulder System 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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