FDA Product Code
FDA Product Code HRX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.1100
510(k) Clearances — 683 records · page 2 of 7
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K123441 | STRYKER CROSSFLOW ARTHROSCOPY PUMP | Stryker Endoscopy | 2013-01-09 | Traditional | PDF ↗ |
| K121261 | ASAP MUITISCOPE | Asap Endoscopic Products GmbH | 2013-01-08 | Traditional | PDF ↗ |
| K122134 | FLEXLITE CAMERA | Spine View, Inc. | 2012-12-27 | Traditional | PDF ↗ |
| K123771 | KYPHON EXPRESS II INFLATABLE BONE TAMPS | Medtronic | 2012-12-21 | Special | PDF ↗ |
| K122861 | XTOOL | Ouroboros Medical | 2012-12-07 | Traditional | PDF ↗ |
| K122662 | VERTIFLEX DIRECT DECOMPRESSION SYSTEM | Vertiflex, Inc. | 2012-11-13 | Traditional | PDF ↗ |
| K121482 | INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERY | Theken Spine, LLC | 2012-08-28 | Traditional | PDF ↗ |
| K121548 | SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS) | Spine View, Inc. | 2012-08-16 | Special | PDF ↗ |
| K112548 | ALTOMEC ARTHROSCOPE | Altomec Endoscopy, Inc. | 2012-08-15 | Abbreviated | PDF ↗ |
| K120553 | ESPIN | Nlt Spine, Ltd. | 2012-08-09 | Traditional | PDF ↗ |
| K120680 | ENSPIRE DISCECTOMY SYSTEM | Spine View, Inc. | 2012-06-26 | Special | PDF ↗ |
| K113352 | TRANSCORP SPINAL ACCESS SYSTEM | Transcorp, Inc. | 2012-04-16 | Traditional | PDF ↗ |
| K113362 | SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS) | Spine View, Inc. | 2012-02-10 | Special | PDF ↗ |
| K113028 | MEDISISS REPROCESSED ARTHROSCOPIC SHAVERS AND BURS | Medisiss | 2011-12-20 | Traditional | PDF ↗ |
| K110992 | ENSPIRE DEBRIDER SYSTEM | Spine View, Inc. | 2011-10-21 | Traditional | PDF ↗ |
| K103231 | KYPHON INFLATION SYRINGE | Medtronic Spine, LLC | 2011-01-24 | Traditional | PDF ↗ |
| K093471 | KARL STORZ ARTHROPUMP POWER IRRIGATION/SUCTION PUMP | KARL STORZ Endoscopy-America, Inc. | 2010-10-18 | Traditional | PDF ↗ |
| K101864 | KYPHON XPANDER II INFLATABLE BONE TAMP | Medtronic | 2010-10-14 | Traditional | PDF ↗ |
| K092723 | AKRO VU VIDEOSCOPIC CARPAL TUNNEL RELEASE (VCTR) SYSTEM | Skeletal Dynamics, LLC | 2010-10-04 | Traditional | PDF ↗ |
| K092977 | EBERLE SHAVER SYSTEM ACCESSORIES | Efs Eberle Feinwerktechnische Systeme | 2010-09-29 | Traditional | PDF ↗ |
| K101734 | VISIONSCOPE HIGH DEFINITION ENDOSCOPY CAMERA SYSTEM WITH; CAMERA CONTROL UNIT; CAMERA HANDPIECE; VISIONSCOPE ENDOSCOPES | Visionscope Technologies, LLC | 2010-09-08 | Traditional | PDF ↗ |
| K093677 | STRYKER ARTHROSCOPE | Stryker Endoscopy | 2010-03-05 | Traditional | PDF ↗ |
| K093717 | C-MOR VISUALIZATION DEVICE | Axis Surgical Technologies, Inc. | 2010-03-02 | Traditional | PDF ↗ |
| K093409 | POWERPUMP ARTHROSCOPY SYSTEM | Medical Vision AB | 2010-02-24 | Traditional | PDF ↗ |
| K093062 | VERTOS MEDICAL MILD DEVICE KIT | X-Sten Corp. | 2010-02-04 | Traditional | PDF ↗ |
| K092877 | INDISCAL ASPIRATION DEVICE AND ACCESSORIES | Baylis Medical Co., Inc. | 2009-11-17 | Traditional | PDF ↗ |
| K083552 | MAXMORESPINE TOM STICK | Hoogland Spine Products, GmbH | 2009-10-09 | Abbreviated | PDF ↗ |
| K082841 | SPINAL FORAMINOSCOPE | Blazejewski Medi-Tech GmbH | 2009-09-09 | Traditional | PDF ↗ |
| K091398 | ARTHROSCOPE | Orthopedic Sciences, Inc. | 2009-08-26 | Traditional | PDF ↗ |
| K083707 | ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE | Arthrex, Inc. | 2009-08-03 | Traditional | PDF ↗ |
| K090132 | MAXMORESPINE SPINAL SYSTEM | Hoogland Spine Products, GmbH | 2009-06-09 | Abbreviated | PDF ↗ |
| K090815 | PERCUTANEOUS DISCECTOMY SYSTEM | Laurimed, LLC | 2009-05-21 | Traditional | PDF ↗ |
| K090303 | XTEND-ST NUCLEUS REMOVAL SYSTEM, MODEL 9004 | Corespine Technologies, LLC | 2009-04-30 | Traditional | PDF ↗ |
| K090278 | ENSPIRE DEBRIDER SYSTEM | Spine View, Inc. | 2009-04-15 | Traditional | PDF ↗ |
| K083161 | ZEN WIRELESS FOOTSWITCH (W1000), ZEN WIRELESS FOOTSWITCH ADAPTER (W1100) | Conmed Linvatec | 2009-03-27 | Traditional | PDF ↗ |
| K081240 | TIGER DISCECTOMY DEVICE | Spinal Devices, LLC | 2009-02-27 | Traditional | PDF ↗ |
| K082355 | VISIONSENSE STEREOSCOPIC VISION SYSTEM | Visionsense, Ltd. | 2008-12-15 | Traditional | PDF ↗ |
| K082293 | SURGVIEW INTEGRATED VISUALIZATION SYSTEM | Biovision Technologies, LLC | 2008-09-09 | Traditional | PDF ↗ |
| K082194 | LAURIMED PERCUTANEOUS DISCECTOMY SYSTEM, MODEL FG-000002 | Laurimed, LLC | 2008-08-28 | Traditional | PDF ↗ |
| K081051 | SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE | Spine View, Inc. | 2008-08-07 | Traditional | PDF ↗ |
| K080122 | SOPRO 670 ARTHROSCOPIC PUMP | Sopro | 2008-07-11 | Traditional | PDF ↗ |
| K080617 | POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES | Richard Wolf Medical Instruments Corp. | 2008-06-27 | Traditional | PDF ↗ |
| K072198 | X-VOID, SPIDER | Sintea Biotech, Inc. | 2008-06-06 | Traditional | PDF ↗ |
| K080560 | HENKE SASS WOLF OF AMERICA ARTHROSCOPE | Henke Sass Wolf of America, Inc. | 2008-03-18 | Traditional | PDF ↗ |
| K072879 | INNERVUE DIAGNOSTIC SCOPE SYSTEM | Biomet Orthopedics, Inc. | 2008-01-14 | Traditional | PDF ↗ |
| K070021 | ITALITE , MODEL 500-3.1, 550-3.1, 600-3.1, 650-3.1, 450-2.0,400-2.0 | Jg Medical Products, LLC | 2007-12-07 | Traditional | PDF ↗ |
| K070874 | ARTHRO KINETICS VESALIUS MR GENERATOR, MODELS 2004-2006; ACCESSORIES FOR MR GENERATOR | Arthro Kinetics, Inc. | 2007-11-02 | Traditional | PDF ↗ |
| K072706 | MICROCHOICE DRILLS AND SAWS, MICROPOWER DRILLS AND SAWS, MICROPOWER ORALMAX HIGH SPEED DRILL | Conmed Linvatec | 2007-10-24 | Special | PDF ↗ |
| K072675 | SMITH & NEPHEW ARTHROSCOPE | Smith & Nephew, Inc. | 2007-10-15 | Special | PDF ↗ |
| K070233 | CONMED LINVATEC SMART GUARD IRRIGATOR | Conmed Linvatec | 2007-04-02 | Special | PDF ↗ |
| K063326 | CONMED LINVATEC 24K IRRIGATION SYSTEM | Conmed Linvatec | 2007-01-31 | Traditional | PDF ↗ |
| K062849 | SMITH & NEPHEW DUONICS POWER II SHAVER SYSTEM | Smith & Nephew, Inc. | 2007-01-19 | Traditional | PDF ↗ |
| K062038 | X-STEN MILD TOOL KIT, MODEL MTK-0001 | X-Sten Corp. | 2006-12-19 | Traditional | PDF ↗ |
| K062380 | FLOSIMPLE ARTHROSCOPY PUMP A120 | W.O.M. World of Medicine AG | 2006-12-14 | Special | PDF ↗ |
| K061134 | EBERLE SHAVER SYSTEM C2 AND SHAVER BLADES | Efs Eberle Feinwerktechnische Systeme | 2006-09-01 | Traditional | PDF ↗ |
| K061246 | ENDOSCOPIC SPINE SYSTEM | Arthro Kinetics, Inc. | 2006-08-23 | Traditional | PDF ↗ |
| K061345 | MODIFICATION TO ENDIUS ATAVI SYSTEM | Endius, Inc. | 2006-06-06 | Special | PDF ↗ |
| K060172 | REMA SHAVER BLADES | Rema Medizintechnik GmbH. | 2006-05-31 | Traditional | PDF ↗ |
| K060198 | MICROPOWER HAND PIECE : MEDIUM SPEED DRILL, SAGGITAL SAW, RECIPROCATING SAW, AND OSCILLATING SAW | Linvatec Corp. | 2006-05-11 | Special | PDF ↗ |
| K053567 | ATHROCARE TOPAZ ARTHROWANDS | Arthrocare Corp. | 2006-03-06 | Traditional | PDF ↗ |
| K052241 | DISC-FX SYSTEM | Ellman International, Inc. | 2006-02-24 | Traditional | PDF ↗ |
| K053267 | ENDIUS ATAVI SYSTEM | Endius, Inc. | 2006-01-13 | Traditional | PDF ↗ |
| K051656 | OCT (OSTEOCHONDRAL TRANSPLANT) COMPREHENSIVE SYSTEM | Osteobiologics, Inc. | 2005-10-25 | Traditional | PDF ↗ |
| K051827 | JOIMAX ENDOSCOPE/MULTISCOPE, THESSYS FORAMINOSCOPE/MULTISCOPE, THESSYS LAMINOSCOPE/MULTISCOPE | Joimax GmbH | 2005-08-12 | Traditional | PDF ↗ |
| K051326 | SMITH & NEPHEW 25 FLUID MANAGEMENT SYSTEM | Smith & Nephew, Inc. | 2005-06-15 | Traditional | PDF ↗ |
| K050580 | SMITH & NEPHEW INTELIJET FLUID MANAGEMENT SYSTEMS | Smith & Nephew Endoscopy, Inc. | 2005-04-20 | Traditional | PDF ↗ |
| K043568 | EQUESTRA FLUID DELIVERY SYSTEM | Medtronic Sofamor Danek | 2005-01-25 | Special | PDF ↗ |
| K043395 | SMITH & NEPHEW VIDEOARTHROSCOPE | Smith & Nephew, Inc. | 2005-01-12 | Traditional | PDF ↗ |
| K041824 | X-TREME ARTHROSCOPIC PUMP AND SHAVER SYSTEM | Future Medical Systems, SA | 2005-01-07 | Traditional | PDF ↗ |
| K041233 | ARTHROJET XT | Hydrocision, Inc. | 2004-07-28 | Special | PDF ↗ |
| K040483 | EQUESTRA FLUID DELIVERY SYSTEM | Medtronic Sofamor Danek, Inc. | 2004-07-23 | Traditional | PDF ↗ |
| K041454 | KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A | Kyphon, Inc. | 2004-07-09 | Traditional | PDF ↗ |
| K040612 | SKY BONE EXPANDER SYSTEM (SKY SYSTEM) | Disc-O-Tech Medical Technologies, Ltd. | 2004-06-17 | Traditional | PDF ↗ |
| K040919 | NUCLEOTOME PROBE SET, MODEL 21200 | Clarus Medical, LLC | 2004-06-01 | Traditional | PDF ↗ |
| K040939 | SKY BONE EXPANDER SYSTEM (SKY SYSTEM) | Disc-O-Tech Medical Technologies, Ltd. | 2004-05-12 | Special | PDF ↗ |
| K041135 | VAPR 3 ELECTROSURGICAL SYSTEM AND VAPR LD AND LP SUCTION ELECTRODES | Depuy Mitek, A Johnson & Johnson Company | 2004-05-10 | Special | PDF ↗ |
| K033573 | LINVATEC 10K IRRIGATION SYSTEM | Linvatec Corp. | 2004-02-11 | Traditional | PDF ↗ |
| K034037 | SKY BONE EXPANDER SYSTEM | Disc-O-Tech Medical Technologies, Ltd. | 2004-01-28 | Special | PDF ↗ |
| K033927 | ARTHOSCOPY PUMP A115 | W.O.M. World of Medicine AG | 2004-01-15 | Special | PDF ↗ |
| K032891 | TRANS1 TRANS-SACRAL SPINAL ACCESS AND PREPARATION KIT | Trans1, Inc. | 2004-01-15 | Traditional | PDF ↗ |
| K032358 | B-TWIN BONE EXPANDER SYSTEM (B-TWIN BE SYSTEM) | Disc-O-Tech Medical Technologies, Ltd. | 2003-12-17 | Traditional | PDF ↗ |
| K032473 | DEKOMPRESSOR PERCUTANEOUS DISCECTOMY PROBE | Stryker Instruments | 2003-11-07 | Traditional | PDF ↗ |
| K030082 | POWER CONTROL 2303 WITH POWER STICK M4, MODEL# 2303.011/.901/.911, 8564.121/.851 | Richard Wolf Medical Instruments Corp. | 2003-10-30 | Traditional | PDF ↗ |
| K032832 | IRRIGATION SETS | Vital Concepts, Inc. | 2003-09-26 | Traditional | PDF ↗ |
| K032529 | HYDROCISION ARTHROJET SYSTEM WITH CAUTERY, TURBOBURR AND CURETTE, MODELS 51300, 51310 | Hydrocision, Inc. | 2003-09-16 | Special | PDF ↗ |
| K031972 | ASAP ARTHROSCOPE MODELS; 10-0001-00, 10-0002-00, 10-0003-00, 10-0004-00, 10-0005-00, 10-0006-00, 10-0007-00, 10-0008-00, | Asap Endoscopic Products GmbH | 2003-09-15 | Traditional | PDF ↗ |
| K032212 | KYPHX DIRECTIONAL INFLATABLE BONE TAMP, MODELS K16A AND K17A | Kyphon, Inc. | 2003-09-15 | Traditional | PDF ↗ |
| K031605 | INTELIJET FLUID MANAGEMENT SYSTEM HERMES-READY | Smith & Nephew, Inc. | 2003-06-18 | Special | PDF ↗ |
| K031406 | EXOJET TISSUE MANAGEMENT SYSTEM | Mitek Worldwide | 2003-05-30 | Traditional | PDF ↗ |
| K030402 | ARTHROSCOPY PUMP, MODEL A107 | W.O.M. World of Medicine AG | 2003-04-17 | Traditional | PDF ↗ |
| K030009 | KSEA POWERSHAVER SYSTEM S2 | Karl Storz Endoscopy | 2003-04-02 | Traditional | PDF ↗ |
| K024291 | ARTHREX CONTINUOUS WAVE III ARTHOSCOPY PUMP, MODEL AR-6475 | Arthrex, Inc. | 2003-03-20 | Traditional | PDF ↗ |
| K030096 | VIDEO ARTHROSCOPE, MODELS AR-3050-30, AR-3050T-30, AR-3050-70, AR-3051-30, AR-3052-30, AR3030AN, AR-3030AS, AR3030AW | Arthrex, Inc. | 2003-03-18 | Traditional | PDF ↗ |
| K030196 | DYONICS POWER CONTROL UNIT | Smith & Nephew, Inc. | 2003-02-20 | Special | PDF ↗ |
| K030307 | DAVOL ARTHROVENT OUTFLOW TUBING | Davol, Inc. | 2003-02-13 | Traditional | PDF ↗ |
| K023783 | SOHNIKS | Sohniks Endoscopy, Inc. | 2003-02-07 | Traditional | PDF ↗ |
| K023777 | ARTHRONET BLACKLINE 2 AND 3 PIECE ARTHROSCOPIC BLADES, MODELS 123, 133, 153, 163, 173 AND 183 | Arthronet Medical, Inc. | 2002-12-11 | Special | PDF ↗ |
| K023187 | KSEA SPINOSCOPE | Karl Storz Endoscopy | 2002-12-02 | Traditional | PDF ↗ |
| K022199 | ENDIUS ATAVI SYSTEM | Endius, Inc. | 2002-10-02 | Traditional | PDF ↗ |
| K020457 | AXIAMED TRANS-SACRAL SPINAL ACCESS DEVICE | Axiamed, Inc. | 2002-09-26 | Traditional | PDF ↗ |
Product code HRX · Class II · Orthopedic. Data: openFDA.