FDA 510(k)

TAG ROD BIORAPTOR SUTURE ANCHOR 7209317, 7209318

K-Number: K031685 · 2003-07-01

Decision Date2003-07-01

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

TAG ROD BIORAPTOR SUTURE ANCHOR 7209317, 7209318 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 2003-07-01 under 510(k) number K031685. 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 TAG ROD BIORAPTOR SUTURE ANCHOR 7209317, 7209318?

TAG ROD BIORAPTOR SUTURE ANCHOR 7209317, 7209318 is a medical device that received FDA 510(k) clearance on 2003-07-01. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K031685.

When did TAG ROD BIORAPTOR SUTURE ANCHOR 7209317, 7209318 receive FDA 510(k) clearance?

TAG ROD BIORAPTOR SUTURE ANCHOR 7209317, 7209318 received FDA 510(k) clearance on 2003-07-01, under 510(k) number K031685.

Who is the listed applicant for TAG ROD BIORAPTOR SUTURE ANCHOR 7209317, 7209318?

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 TAG ROD BIORAPTOR SUTURE ANCHOR 7209317, 7209318?

The FDA product code for TAG ROD BIORAPTOR SUTURE ANCHOR 7209317, 7209318 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.