FDA 510(k)

Smith & Nephew Intramedullary Nail Systems

K-Number: K210980 · 2022-11-14

Decision Date2022-11-14

Product CodeHSB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Smith & Nephew Intramedullary Nail Systems 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 2022-11-14 under 510(k) number K210980. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Smith & Nephew Intramedullary Nail Systems?

Smith & Nephew Intramedullary Nail Systems is a medical device that received FDA 510(k) clearance on 2022-11-14. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K210980.

When did Smith & Nephew Intramedullary Nail Systems receive FDA 510(k) clearance?

Smith & Nephew Intramedullary Nail Systems received FDA 510(k) clearance on 2022-11-14, under 510(k) number K210980.

Who is the listed applicant for Smith & Nephew Intramedullary Nail Systems?

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 Intramedullary Nail Systems?

The FDA product code for Smith & Nephew Intramedullary Nail Systems is HSB.

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Other records listing Smith & Nephew, Inc. as applicant

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 PMA P000057Finger semi-constrained pyrolytic carbon uncemented prosthesis 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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Related Devices (Code: HSB)

K261481Pangea Femur Reconstruction SystemStryker GmbH K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized Orthopedics K253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.K260146FITBONE® TRANSPORT AND LENGTHENING SYSTEMOrthofix Srl

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.