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FDA 510(k)

BIOBUCK CEMENT RESTRICTOR

K-Number: K023680 · 2002-11-19

ApplicantSmith & Nephew, Inc.
Decision Date2002-11-19
Product CodeLZN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BIOBUCK CEMENT RESTRICTOR 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 2002-11-19 under 510(k) number K023680. The device is classified under product code LZN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOBUCK CEMENT RESTRICTOR?

BIOBUCK CEMENT RESTRICTOR is a medical device that received FDA 510(k) clearance on 2002-11-19. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K023680.

When did BIOBUCK CEMENT RESTRICTOR receive FDA 510(k) clearance?

BIOBUCK CEMENT RESTRICTOR received FDA 510(k) clearance on 2002-11-19, under 510(k) number K023680.

Who is the listed applicant for BIOBUCK CEMENT RESTRICTOR?

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 BIOBUCK CEMENT RESTRICTOR?

The FDA product code for BIOBUCK CEMENT RESTRICTOR is LZN.

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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.

K261462LANDMARK Total Knee SystemK261968Q-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 GlenoidsK252416AETOS 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)

View all 509 devices →

Related Devices (Code: LZN)

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.

K220838Artisan Bone Plug, Universal Cement RestrictorHowmedica Osteonics, Dba Stryker OrthopaedicsK061824TORNIER CEMENT RESTRICTORTornierK032685CEMSTOP CEMENT RESTRICTORTeknimed, S.A.K011943IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTORKensey Nash Corp.K010840SYNPLUGIsotis NVK000587SHUTTLE STOPIsotis NV

Official Source

View on FDA Database →

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

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