FDA Product Code
FDA Product Code KTT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3030
510(k) Clearances — 405 records · page 2 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K140961 | HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM | Stryker Trauma AG | 2014-11-10 | Traditional | PDF ↗ |
| K141912 | AOS SMALL BONE EXTERNAL FIXATION, THREADED HALF PINS, AOS SMALL BONE EXTERNAL FIXATION, CARBON FIBER RODS, AOS SMALL BON | Advanced Orthopaedic Solutions, Inc. | 2014-10-29 | Traditional | PDF ↗ |
| K140463 | INTEGRA EXTERNAL FIXATION SYSTEM | Ascension Orthopedic | 2014-10-10 | Traditional | PDF ↗ |
| K141697 | XTRAFIX EXTERNAL FIXATION SYSTEM, XTRAFIX SMALL EXTERNAL FIXATION SYSTEM | Zimmer, Inc. | 2014-09-18 | Traditional | PDF ↗ |
| K141078 | ORTHOFIX TL-HEX TRUE LOK HEXALOBE SYSTEM (TL-HEX) | Orthofix Srl | 2014-09-02 | Traditional | PDF ↗ |
| K140675 | EMERGE EXTERNAL FIXATION SYSTEM | Emerge Medical, Inc. | 2014-06-10 | Traditional | PDF ↗ |
| K140822 | DRIVE RAIL SYSTEM | Devise Ortho, Inc. | 2014-05-29 | Traditional | PDF ↗ |
| K140158 | S.E.A.L. FRACTURE FUSION TUBE | Dne, LLC | 2014-05-29 | Traditional | PDF ↗ |
| K131413 | XTRAFIX SMALL EXTERNAL FIXATION SYSTEM | Zimmer, Inc. | 2014-01-28 | Traditional | PDF ↗ |
| K132363 | DOLPHIX EXTERNAL FIXATION SYSTEM | Citieffe S.R.L. | 2014-01-16 | Traditional | PDF ↗ |
| K130907 | HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM | Stryker Trauma AG | 2013-06-10 | Traditional | PDF ↗ |
| K122777 | NBX - NON BRIDGING EXTERNAL FIXATOR HAND | Nutek Orthopaedics, Inc. | 2013-05-15 | Traditional | PDF ↗ |
| K130479 | ILIZAROV DRILL TIP WIRES | Smith & Nephew, Inc. | 2013-05-14 | Traditional | PDF ↗ |
| K130334 | HOFFMANN LRF (LIMB RECONSTRUCTION FRAME SYSTEM) | Stryker Trauma AG | 2013-05-03 | Traditional | PDF ↗ |
| K122210 | NEWFIX EXTERNAL FIXATION SYSTEM | Tecnologia Y Diseno Industrial, S.A DE C.V | 2013-04-19 | Traditional | PDF ↗ |
| K122455 | SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM | Synthes | 2013-04-11 | Traditional | PDF ↗ |
| K130044 | SIDEKICK EZ FRAME EXTERNAL FIXATION SYSTEM | Wrightmedicaltechnologyinc | 2013-04-05 | Traditional | PDF ↗ |
| K122284 | HOFFMANN 3 | Stryker Corp. | 2012-10-24 | Traditional | PDF ↗ |
| K113770 | ORTHOFIX GALAXY FIXATION SYSTEM | Orthofix Srl | 2012-09-04 | Traditional | PDF ↗ |
| K121252 | HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM | Stryker Corp. | 2012-07-25 | Traditional | PDF ↗ |
| K113383 | XTRAFIX EXTERNAL FIXATION SYSTEM | Extraortho, Inc. | 2012-06-26 | Traditional | PDF ↗ |
| K113384 | EXTERNAL FIXATOR ST.A R 90 F4 | Citieffe | 2012-05-01 | Traditional | PDF ↗ |
| K113327 | HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM | Stryker Corp. | 2012-03-29 | Traditional | PDF ↗ |
| K111786 | HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM | Stryker Corp. | 2012-01-26 | Traditional | PDF ↗ |
| K113123 | OIC CANNULATED SCREW SYSTEM, OIC SLIDING HIP SCREW (SHS) SYSTEM | The Orthopaedic Implant Company | 2012-01-12 | Traditional | PDF ↗ |
| K113106 | DNE EXTERNAL FIXATION SYSTEM | Dne, LLC | 2012-01-04 | Traditional | PDF ↗ |
| K112218 | ACE-FISCHER(R), TEMPFIX(R), HOFFMAN CLASSIC(TM) EXTERNAL FIXATORS | DePuy Orthopaedics, Inc. | 2011-12-15 | Traditional | PDF ↗ |
| K110426 | DYNA-EXTOR II | Bk Meditech, Co., Ltd. | 2011-11-02 | Traditional | PDF ↗ |
| K111993 | FRAMEWALKER | Quantum Medical Concepts, LLC | 2011-10-24 | Traditional | PDF ↗ |
| K111155 | XTRAFIX EXTERNAL FIXATION SYSTEM | Extraortho, Inc. | 2011-10-20 | Traditional | PDF ↗ |
| K111376 | CONSTRUX EXTERNAL FIXATION DEVICE | Ebi, LLC | 2011-08-03 | Traditional | PDF ↗ |
| K110965 | RENOVIS T 710 LARGE EXTERNAL FIXATION SYSTEM | Renovis Surgical Technologies, LLC | 2011-05-11 | Traditional | PDF ↗ |
| K102843 | MAC MALE ADAPTER | Biomet Trauma (Aka Ebi, LLC) | 2011-05-03 | Special | PDF ↗ |
| K103015 | ODRC-DYNAMIC HIP SCREW SYSTEM | Orthopaedic Device Research Center | 2011-04-13 | Traditional | PDF ↗ |
| K101338 | NEWFIX EXTERNAL FIXATION SYSTEM | Technologia Y Diseno Industrial, S.A DE C.V | 2011-03-14 | Traditional | PDF ↗ |
| K110069 | SMITH & NEPHEW, INC SPATIALFRAME V4.1 WEB-BASED SOFTWARE | Smith & Nephew, Inc. | 2011-02-08 | Special | PDF ↗ |
| K102057 | TARGON FN SYSTEM | Aesculap Implant Systems, LLC | 2010-12-21 | Traditional | PDF ↗ |
| K102688 | MERETE LOCKING BONE PLATE SYSTEM II | Merete Medical GmbH | 2010-12-03 | Traditional | PDF ↗ |
| K101759 | QUANTUM RING FIXATION SYSTEM MODEL ISF | Quantum Medical Concepts, LLC | 2010-10-22 | Traditional | PDF ↗ |
| K093047 | SMITH & NEPHEW CIRCULAR FIXATION SYSTEM | Smith & Nephew, Inc. | 2010-09-27 | Traditional | PDF ↗ |
| K101170 | ACUTE INNOVATIONS STERNAL FIXATION SYSTEM | Acute Innovations, LLC | 2010-09-17 | Traditional | PDF ↗ |
| K100795 | JET-X BAR SYSTEM CLAMPS AND POSTS REPROCESSING | Smith & Nephew, Inc. | 2010-09-02 | Traditional | PDF ↗ |
| K093753 | MDPO FRAME SYSTEM | Mdpo, LLC | 2010-08-26 | Traditional | PDF ↗ |
| K100137 | SIDEKICK CIRCULAR FIXATOR SYSTEM: STRUTS AND HINGES | Wrightmedicaltechnologyinc | 2010-06-10 | Special | PDF ↗ |
| K100857 | FUSION MEDICAL RING LOCK SYSTEM | John J Riccio | 2010-05-27 | Traditional | PDF ↗ |
| K092190 | SYNTHES DISTRACTION OSTEOGENESIS SYSTEM, MR CONDITIONAL WITH EXPANDED INDICATIONS | Synthes (Usa) | 2010-05-11 | Traditional | PDF ↗ |
| K090658 | SYNTHES EXTERNAL FIXATION DEVICES, MR CONDITIONAL | Synthes (Usa) | 2010-03-03 | Traditional | PDF ↗ |
| K093550 | MINI RAIL EXTERNAL FIXATOR SYSTEM | Small Bone Innovations, Inc. | 2010-01-07 | Special | PDF ↗ |
| K092002 | AFGHAN EXTERNAL FIXATOR | Smith & Nephew, Inc. | 2009-12-10 | Traditional | PDF ↗ |
| K093057 | BIOMET VISION FOOTRING SYSTEM | Ebi, L.P. | 2009-12-01 | Traditional | PDF ↗ |
| K092834 | HOFFMAN XPRESS LINE EXTENSION | Howmedica Osteonics Corp. | 2009-10-08 | Special | PDF ↗ |
| K091619 | ANGLEFIX T LOCKING PLATE, MODELS AF-001 (PLATE), ST-1 (LOCKING SCREW) | Anglefix | 2009-09-08 | Traditional | PDF ↗ |
| K083582 | SIGN HIP CONSTRUCT (SHC), MODEL: 701 | Surgical Implant Generation Network (Sign) | 2009-08-26 | Traditional | PDF ↗ |
| K091258 | EXTRAFIX EXTERNAL FIXATION SYSTEM | Qfx Technologies, Inc. | 2009-07-24 | Traditional | PDF ↗ |
| K090926 | SMITH & NEPHEW RAIL SYSTEM | Smith & Nephew, Inc. | 2009-06-08 | Traditional | PDF ↗ |
| K090063 | MERETE LOCKING BONE PLATE SYSTEM | Merete Medical, Inc. | 2009-04-22 | Traditional | PDF ↗ |
| K083789 | ACE FISCHER EXTERNAL FIXATION SYSTEM | DePuy Orthopaedics, Inc. | 2009-03-23 | Traditional | PDF ↗ |
| K083636 | REPROCESSED EXTERNAL FIXATION DEVICE | Sterilmed, Inc. | 2009-03-02 | Traditional | PDF ↗ |
| K082833 | NBX - NON-BRIDGING EXTERNAL FIXATOR - SHOULDER | Nutek Orthopaedics, Inc. | 2009-02-05 | Traditional | PDF ↗ |
| K082650 | SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONAL | Synthes (Usa) | 2008-11-18 | Traditional | PDF ↗ |
| K081586 | REPROCESSED EXTERNAL FIXATION DEVICE | Sterilmed, Inc. | 2008-08-18 | Traditional | PDF ↗ |
| K081342 | REPROCESSED EXTERNAL FIXATION ACCESSORIES | Sterilmed, Inc. | 2008-08-13 | Traditional | PDF ↗ |
| K081244 | LOWER EXTREMITY EXTERNAL FIXATION - EXPANDED INDICATIONS | Biomet Trauma | 2008-07-30 | Traditional | PDF ↗ |
| K081284 | VARIAX DISTAL FIBULA PLATE | Howmedica Osteonics Corp. | 2008-07-18 | Traditional | PDF ↗ |
| K081278 | OMEGA 3 TROCHANTERIC STABILIZING PLATE | Howmedica Osteonics Corp. | 2008-05-29 | Special | PDF ↗ |
| K080408 | EXTERNAL FIXATION CLAMP 5.0 MM PIN X9.5MM ROD, MODEL 1151-100, EXTERNAL FIXATON CLAMP, 9.5MM ROD | Advanced Orthopaedic Solutions, Inc. | 2008-04-25 | Traditional | PDF ↗ |
| K072212 | JET-X BAR SYSTEM CLAMPS, BARS AND POSTS-MR SAFE | Smith & Nephew, Inc. | 2008-03-07 | Special | PDF ↗ |
| K073076 | HOFFMANN LIGHT SYSTEM | Howmedica Osteonics Corp. | 2008-02-15 | Traditional | PDF ↗ |
| K073527 | VARIAX ELBOW SYSTEM | Howmedica Osteonics Corp. | 2008-02-14 | Traditional | PDF ↗ |
| K080071 | SIDEKICK RAIL FIXATOR | Wrightmedicaltechnologyinc | 2008-02-07 | Special | PDF ↗ |
| K072250 | SUPERCABLE GRIP AND PLATE SYSTEM | Kinamed, Inc. | 2007-11-09 | Traditional | PDF ↗ |
| K071852 | AAP APS SYSTEM | Aap Implantate AG | 2007-08-29 | Traditional | PDF ↗ |
| K071395 | BIOMET VISION FOOTRING SYSTEM | Biomet Manufacturing Corp | 2007-07-09 | Traditional | PDF ↗ |
| K071394 | MODIFICATION TO:SBI RINGFIX | Small Bone Innovations, Inc. | 2007-06-29 | Special | PDF ↗ |
| K070724 | IOS EXTERNAL FIXATOR, MODEL 2-0-0 | Intelligent Orthopaedics, Ltd. | 2007-05-16 | Traditional | PDF ↗ |
| K070454 | OMEGA 3 SUPRACONDYLAR PLATE | Howmedica Osteonics Corp. | 2007-04-12 | Special | PDF ↗ |
| K070016 | BLUE SHARK | Meridan Medical | 2007-04-02 | Traditional | PDF ↗ |
| K063487 | MERETE BLP SMALL FRAGMENT LOCKING BONE PLATE | Merete Medical GmbH | 2007-01-22 | Traditional | PDF ↗ |
| K063509 | DEPUY PEAK FX HIP PLATE | DePuy Orthopaedics, Inc. | 2007-01-04 | Traditional | PDF ↗ |
| K063551 | AEQUALIS HUMERAL PLATE | Tornier | 2006-12-22 | Special | PDF ↗ |
| K061759 | REPROCESSED EXTERNAL FIXATION DEVICE | Ascent Healthcare Solutions | 2006-09-05 | Traditional | PDF ↗ |
| K062066 | OMEGA 3 SYSTEM | Howmedica Osteonics Corp. | 2006-08-15 | Special | PDF ↗ |
| K061748 | FRAGMENT PLATE SYSTEM | Hand Innovations, LLC | 2006-07-17 | Special | PDF ↗ |
| K060545 | UNITY HUMERAL PLATE | Tornier | 2006-04-21 | Traditional | PDF ↗ |
| K060613 | VARIAX LOCKING PLATE SYSTEM | Howmedica Osteonics Corp. | 2006-04-21 | Traditional | PDF ↗ |
| K052918 | REPROCESSED EXTERNAL FIXATION DEVICES | Alliance Medical Corp. | 2006-01-27 | Traditional | PDF ↗ |
| K053472 | HOFFMANN II MRI EXTERNAL FIXATION SYSTEM | Howmedica Osteonics Corp. | 2006-01-11 | Special | PDF ↗ |
| K053051 | VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES | Vanguard Medical Concepts, Inc. | 2005-12-22 | Traditional | PDF ↗ |
| K053349 | HOFFMANN II ROD TO WIRE COUPLING | Howmedica Osteonics Corp. | 2005-12-09 | Special | PDF ↗ |
| K053038 | HOFFMANN II COMPACT MRI EXTERNAL FIXATION SYSTEM | Howmedica Osteonics Corp. | 2005-11-22 | Special | PDF ↗ |
| K052196 | VILEX X-FIX | Vilex, Inc. | 2005-11-22 | Traditional | PDF ↗ |
| K052605 | EXTERNAL FIXATION | Gexfix USA, Inc. | 2005-11-10 | Traditional | PDF ↗ |
| K052498 | FRAGMENT SPECIFIC FIXATOR | David J. Slutsky MD | 2005-10-17 | Traditional | PDF ↗ |
| K051957 | REPROCESSED EXTERNAL FIXATION DEVICE | Sterilemed, Inc. | 2005-09-21 | Traditional | PDF ↗ |
| K052239 | EBI DYNAFIX VISION FOOTPLATE SYSTEM | Ebi, L.P. | 2005-09-21 | Traditional | PDF ↗ |
| K051616 | VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES | Vanguard Medical Concepts, Inc. | 2005-09-06 | Traditional | PDF ↗ |
| K052005 | R&R EXTERNAL FIXATION SYSTEM | R&R Medical, Inc. | 2005-09-06 | Traditional | PDF ↗ |
| K052062 | ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES | Alliance Medical Corp. | 2005-08-25 | Special | PDF ↗ |
| K052064 | ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES | Alliance Medical Corp. | 2005-08-25 | Special | PDF ↗ |
| K052065 | ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES | Alliance Medical Corp. | 2005-08-22 | Special | PDF ↗ |
Product code KTT · Class II · Orthopedic. Data: openFDA.