FDA 510(k)

SMITH & NEPHEW SUTURE ANCHOR

K-Number: K003599 · 2001-02-15

Decision Date2001-02-15

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

SMITH & NEPHEW SUTURE ANCHOR 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 2001-02-15 under 510(k) number K003599. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMITH & NEPHEW SUTURE ANCHOR?

SMITH & NEPHEW SUTURE ANCHOR is a medical device that received FDA 510(k) clearance on 2001-02-15. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K003599.

When did SMITH & NEPHEW SUTURE ANCHOR receive FDA 510(k) clearance?

SMITH & NEPHEW SUTURE ANCHOR received FDA 510(k) clearance on 2001-02-15, under 510(k) number K003599.

Who is the listed applicant for SMITH & NEPHEW SUTURE ANCHOR?

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 SMITH & NEPHEW SUTURE ANCHOR?

The FDA product code for SMITH & NEPHEW SUTURE ANCHOR is HWC. This falls under the Cardiovascular category.

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Other records listing Smith & Nephew, Inc. as applicant

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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.