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FDA 510(k)

TANDEM Hip System

K-Number: K231448 · 2023-07-19

ApplicantSmith & Nephew, Inc.
Decision Date2023-07-19
Product CodeLZY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TANDEM Hip 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 2023-07-19 under 510(k) number K231448. The device is classified under product code LZY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TANDEM Hip System?

TANDEM Hip System is a medical device that received FDA 510(k) clearance on 2023-07-19. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K231448.

When did TANDEM Hip System receive FDA 510(k) clearance?

TANDEM Hip System received FDA 510(k) clearance on 2023-07-19, under 510(k) number K231448.

Who is the listed applicant for TANDEM Hip 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 TANDEM Hip System?

The FDA product code for TANDEM Hip System is LZY.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Smith & Nephew, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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 GlenoidsPMA P000057Finger semi-constrained pyrolytic carbon uncemented prosthesisK252416AETOS Shoulder System Meta Humeral Prosthesis Size 0K252129AETOS Shoulder System Stemless Humeral ProsthesisK251627BIORAPTOR 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.

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