FDA 510(k)

JET-X BAR SYSTEM CLAMPS AND POSTS REPROCESSING

K-Number: K100795 · 2010-09-02

Decision Date2010-09-02

Product CodeKTT

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

JET-X BAR SYSTEM CLAMPS AND POSTS REPROCESSING 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 2010-09-02 under 510(k) number K100795. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JET-X BAR SYSTEM CLAMPS AND POSTS REPROCESSING?

JET-X BAR SYSTEM CLAMPS AND POSTS REPROCESSING is a medical device that received FDA 510(k) clearance on 2010-09-02. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K100795.

When did JET-X BAR SYSTEM CLAMPS AND POSTS REPROCESSING receive FDA 510(k) clearance?

JET-X BAR SYSTEM CLAMPS AND POSTS REPROCESSING received FDA 510(k) clearance on 2010-09-02, under 510(k) number K100795.

Who is the listed applicant for JET-X BAR SYSTEM CLAMPS AND POSTS REPROCESSING?

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 JET-X BAR SYSTEM CLAMPS AND POSTS REPROCESSING?

The FDA product code for JET-X BAR SYSTEM CLAMPS AND POSTS REPROCESSING is KTT.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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)

View all 509 devices →

Related Devices (Code: KTT)

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLC K260900DYNEX® External Fixation SystemsVilex, LLC K260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.K253291Excelsior SystemBlue Ocean Global K253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.K253202Hoffmann LRF SystemStryker GmbH

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.