ClearanceBrief
Panels › Orthopedic › Product code KTT · Class 2

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Regulation 888.3030

9510(k)s in 12 months (405 all time)
11recalls in 12 months (89 all time)
85recalls that name a 510(k)
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Top companies in KTT

Company510(k)sRecalls
Ebi, L.P.362
Synthes331
Stryker Corp.1115
Orthofix Srl1112
Howmedica Corp.220
Howmedica Osteonics Corp.191
Zimmer, Inc.109
Smith & Nephew160
Wrightmedicaltechnologyinc110
Alliance Medical Corp.90
Decided510(k)Device and applicantCode
Oct 8, 2009K092834HOFFMAN XPRESS LINE EXTENSION
Howmedica Osteonics Corp.
KTT
Sep 8, 2009K091619ANGLEFIX T LOCKING PLATE, MODELS AF-001 (PLATE), ST-1 (LOCKING SCREW)
Anglefix
KTT
Aug 26, 2009K083582SIGN HIP CONSTRUCT (SHC), MODEL: 701
Surgical Implant Generation Network (Sign)
KTT
Jul 24, 2009K091258EXTRAFIX EXTERNAL FIXATION SYSTEM
Qfx Technologies, Inc.
KTT
Jun 8, 2009K090926SMITH & NEPHEW RAIL SYSTEM
Smith & Nephew, Inc.
KTT
Apr 22, 2009K090063MERETE LOCKING BONE PLATE SYSTEM
Merete Medical, Inc.
KTT
Mar 23, 2009K083789ACE FISCHER EXTERNAL FIXATION SYSTEM
DePuy Orthopaedics, Inc.
KTT
Mar 2, 2009K083636REPROCESSED EXTERNAL FIXATION DEVICE
Sterilmed, Inc.
KTT
Feb 5, 2009K082833NBX - NON-BRIDGING EXTERNAL FIXATOR - SHOULDER
Nutek Orthopaedics, Inc.
KTT
Nov 18, 2008K082650SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONAL
Synthes (Usa)
KTT
Aug 18, 2008K081586REPROCESSED EXTERNAL FIXATION DEVICE
Sterilmed, Inc.
KTT
Aug 13, 2008K081342REPROCESSED EXTERNAL FIXATION ACCESSORIES
Sterilmed, Inc.
KTT
Jul 30, 2008K081244LOWER EXTREMITY EXTERNAL FIXATION - EXPANDED INDICATIONS
Biomet Trauma
KTT
Jul 18, 2008K081284VARIAX DISTAL FIBULA PLATE
Howmedica Osteonics Corp.
KTT
May 29, 2008K081278OMEGA 3 TROCHANTERIC STABILIZING PLATE
Howmedica Osteonics Corp.
KTT
Apr 25, 2008K080408EXTERNAL FIXATION CLAMP 5.0 MM PIN X9.5MM ROD, MODEL 1151-100, EXTERNAL FIXATON CLAMP, 9.5MM ROD
Advanced Orthopaedic Solutions, Inc.
KTT
Mar 7, 2008K072212JET-X BAR SYSTEM CLAMPS, BARS AND POSTS-MR SAFE
Smith & Nephew, Inc.
KTT
Feb 15, 2008K073076HOFFMANN LIGHT SYSTEM
Howmedica Osteonics Corp.
KTT
Feb 14, 2008K073527VARIAX ELBOW SYSTEM
Howmedica Osteonics Corp.
KTT
Feb 7, 2008K080071SIDEKICK RAIL FIXATOR
Wrightmedicaltechnologyinc
KTT
Nov 9, 2007K072250SUPERCABLE GRIP AND PLATE SYSTEM
Kinamed, Inc.
KTT
Aug 29, 2007K071852AAP APS SYSTEM
Aap Implantate AG, DE
KTT
Jul 9, 2007K071395BIOMET VISION FOOTRING SYSTEM
Biomet Manufacturing Corp
KTT
Jun 29, 2007K071394MODIFICATION TO:SBI RINGFIX
Small Bone Innovations, Inc.
KTT
May 16, 2007K070724IOS EXTERNAL FIXATOR, MODEL 2-0-0
Intelligent Orthopaedics, Ltd., GB
KTT
Apr 12, 2007K070454OMEGA 3 SUPRACONDYLAR PLATE
Howmedica Osteonics Corp.
KTT
Apr 2, 2007K070016BLUE SHARK
Meridan Medical
KTT
Jan 22, 2007K063487MERETE BLP SMALL FRAGMENT LOCKING BONE PLATE
Merete Medical GmbH
KTT
Jan 4, 2007K063509DEPUY PEAK FX HIP PLATE
DePuy Orthopaedics, Inc.
KTT
Dec 22, 2006K063551AEQUALIS HUMERAL PLATE
Tornier, FR
KTT
Sep 5, 2006K061759REPROCESSED EXTERNAL FIXATION DEVICE
Ascent Healthcare Solutions
KTT
Aug 15, 2006K062066OMEGA 3 SYSTEM
Howmedica Osteonics Corp.
KTT
Jul 17, 2006K061748FRAGMENT PLATE SYSTEM
Hand Innovations, LLC
KTT
Apr 21, 2006K060613VARIAX LOCKING PLATE SYSTEM
Howmedica Osteonics Corp.
KTT
Apr 21, 2006K060545UNITY HUMERAL PLATE
Tornier, FR
KTT
Jan 27, 2006K052918REPROCESSED EXTERNAL FIXATION DEVICES
Alliance Medical Corp.
KTT
Jan 11, 2006K053472HOFFMANN II MRI EXTERNAL FIXATION SYSTEM
Howmedica Osteonics Corp.
KTT
Dec 22, 2005K053051VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES
Vanguard Medical Concepts, Inc.
KTT
Dec 9, 2005K053349HOFFMANN II ROD TO WIRE COUPLING
Howmedica Osteonics Corp.
KTT
Nov 22, 2005K053038HOFFMANN II COMPACT MRI EXTERNAL FIXATION SYSTEM
Howmedica Osteonics Corp.
KTT
Nov 22, 2005K052196VILEX X-FIX
Vilex, Inc.
KTT
Nov 10, 2005K052605EXTERNAL FIXATION
Gexfix USA, Inc.
KTT
Oct 17, 2005K052498FRAGMENT SPECIFIC FIXATOR
David J. Slutsky MD
KTT
Sep 21, 2005K052239EBI DYNAFIX VISION FOOTPLATE SYSTEM
Ebi, L.P.
KTT
Sep 21, 2005K051957REPROCESSED EXTERNAL FIXATION DEVICE
Sterilemed, Inc.
KTT
Sep 6, 2005K052005R&R EXTERNAL FIXATION SYSTEM
R&R Medical, Inc.
KTT
Sep 6, 2005K051616VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES
Vanguard Medical Concepts, Inc.
KTT
Aug 25, 2005K052064ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES
Alliance Medical Corp.
KTT
Aug 25, 2005K052062ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES
Alliance Medical Corp.
KTT
Aug 22, 2005K052065ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES
Alliance Medical Corp.
KTT

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