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
Nov 10, 2014K140961HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM
Stryker Trauma AG, CH
KTT
Oct 29, 2014K141912AOS SMALL BONE EXTERNAL FIXATION, THREADED HALF PINS, AOS SMALL BONE EXTERNAL FIXATION, CARBON FIBER RODS, AOS SMALL BON
Advanced Orthopaedic Solutions, Inc.
KTT
Oct 10, 2014K140463INTEGRA EXTERNAL FIXATION SYSTEM
Ascension Orthopedic
KTT
Sep 18, 2014K141697XTRAFIX EXTERNAL FIXATION SYSTEM, XTRAFIX SMALL EXTERNAL FIXATION SYSTEM
Zimmer, Inc.
KTT
Sep 2, 2014K141078ORTHOFIX TL-HEX TRUE LOK HEXALOBE SYSTEM (TL-HEX)
Orthofix Srl
KTT
Jun 10, 2014K140675EMERGE EXTERNAL FIXATION SYSTEM
Emerge Medical, Inc.
KTT
May 29, 2014K140822DRIVE RAIL SYSTEM
Devise Ortho, Inc.
KTT
May 29, 2014K140158S.E.A.L. FRACTURE FUSION TUBE
Dne, LLC
KTT
Jan 28, 2014K131413XTRAFIX SMALL EXTERNAL FIXATION SYSTEM
Zimmer, Inc.
KTT
Jan 16, 2014K132363DOLPHIX EXTERNAL FIXATION SYSTEM
Citieffe S.R.L.
KTT
Jun 10, 2013K130907HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM
Stryker Trauma AG
KTT
May 15, 2013K122777NBX - NON BRIDGING EXTERNAL FIXATOR HAND
Nutek Orthopaedics, Inc.
KTT
May 14, 2013K130479ILIZAROV DRILL TIP WIRES
Smith & Nephew, Inc.
KTT
May 3, 2013K130334HOFFMANN LRF (LIMB RECONSTRUCTION FRAME SYSTEM)
Stryker Trauma AG
KTT
Apr 19, 2013K122210NEWFIX EXTERNAL FIXATION SYSTEM
Tecnologia Y Diseno Industrial, S.A DE C.V
KTT
Apr 11, 2013K122455SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM
Synthes
KTT
Apr 5, 2013K130044SIDEKICK EZ FRAME EXTERNAL FIXATION SYSTEM
Wrightmedicaltechnologyinc
KTT
Oct 24, 2012K122284HOFFMANN 3
Stryker Corp.
KTT
Sep 4, 2012K113770ORTHOFIX GALAXY FIXATION SYSTEM
Orthofix Srl
KTT
Jul 25, 2012K121252HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM
Stryker Corp.
KTT
Jun 26, 2012K113383XTRAFIX EXTERNAL FIXATION SYSTEM
Extraortho, Inc.
KTT
May 1, 2012K113384EXTERNAL FIXATOR ST.A R 90 F4
Citieffe
KTT
Mar 29, 2012K113327HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM
Stryker Corp.
KTT
Jan 26, 2012K111786HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM
Stryker Corp.
KTT
Jan 12, 2012K113123OIC CANNULATED SCREW SYSTEM, OIC SLIDING HIP SCREW (SHS) SYSTEM
The Orthopaedic Implant Company
KTT
Jan 4, 2012K113106DNE EXTERNAL FIXATION SYSTEM
Dne, LLC
KTT
Dec 15, 2011K112218ACE-FISCHER(R), TEMPFIX(R), HOFFMAN CLASSIC(TM) EXTERNAL FIXATORS
DePuy Orthopaedics, Inc.
KTT
Nov 2, 2011K110426DYNA-EXTOR II
Bk Meditech, Co., Ltd.
KTT
Oct 24, 2011K111993FRAMEWALKER
Quantum Medical Concepts, LLC
KTT
Oct 20, 2011K111155XTRAFIX EXTERNAL FIXATION SYSTEM
Extraortho, Inc.
KTT
Aug 3, 2011K111376CONSTRUX EXTERNAL FIXATION DEVICE
Ebi, LLC
KTT
May 11, 2011K110965RENOVIS T 710 LARGE EXTERNAL FIXATION SYSTEM
Renovis Surgical Technologies, LLC
KTT
May 3, 2011K102843MAC MALE ADAPTER
Biomet Trauma (Aka Ebi, LLC)
KTT
Apr 13, 2011K103015ODRC-DYNAMIC HIP SCREW SYSTEM
Orthopaedic Device Research Center, TW
KTT
Mar 14, 2011K101338NEWFIX EXTERNAL FIXATION SYSTEM
Technologia Y Diseno Industrial, S.A DE C.V
KTT
Feb 8, 2011K110069SMITH & NEPHEW, INC SPATIALFRAME V4.1 WEB-BASED SOFTWARE
Smith & Nephew, Inc.
KTT
Dec 21, 2010K102057TARGON FN SYSTEM
Aesculap Implant Systems, LLC
KTT
Dec 3, 2010K102688MERETE LOCKING BONE PLATE SYSTEM II
Merete Medical GmbH
KTT
Oct 22, 2010K101759QUANTUM RING FIXATION SYSTEM MODEL ISF
Quantum Medical Concepts, LLC
KTT
Sep 27, 2010K093047SMITH & NEPHEW CIRCULAR FIXATION SYSTEM
Smith & Nephew, Inc.
KTT
Sep 17, 2010K101170ACUTE INNOVATIONS STERNAL FIXATION SYSTEM
Acute Innovations, LLC
KTT
Sep 2, 2010K100795JET-X BAR SYSTEM CLAMPS AND POSTS REPROCESSING
Smith & Nephew, Inc.
KTT
Aug 26, 2010K093753MDPO FRAME SYSTEM
Mdpo, LLC
KTT
Jun 10, 2010K100137SIDEKICK CIRCULAR FIXATOR SYSTEM: STRUTS AND HINGES
Wrightmedicaltechnologyinc
KTT
May 27, 2010K100857FUSION MEDICAL RING LOCK SYSTEM
John J Riccio
KTT
May 11, 2010K092190SYNTHES DISTRACTION OSTEOGENESIS SYSTEM, MR CONDITIONAL WITH EXPANDED INDICATIONS
Synthes (Usa)
KTT
Mar 3, 2010K090658SYNTHES EXTERNAL FIXATION DEVICES, MR CONDITIONAL
Synthes (Usa)
KTT
Jan 7, 2010K093550MINI RAIL EXTERNAL FIXATOR SYSTEM
Small Bone Innovations, Inc.
KTT
Dec 10, 2009K092002AFGHAN EXTERNAL FIXATOR
Smith & Nephew, Inc.
KTT
Dec 1, 2009K093057BIOMET VISION FOOTRING SYSTEM
Ebi, L.P.
KTT

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