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 1 of 7
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260203 | Fule Vertebroplasty Balloon Catheter | Beijing Fule Science & Technology Development Co., Ltd. | 2026-08-28 | Traditional | PDF ↗ |
| K254103 | HOPKINS Telescopes for Arthroscopy | Karl Storz SE & CO. KG | 2026-08-26 | Traditional | PDF ↗ |
| K252790 | Digital ClarusScope System and Digital NeuroPEN System | Clarus Medical, LLC | 2026-05-26 | Traditional | PDF ↗ |
| K253523 | Freedom DS Decompression System | Spinal Simplicity | 2026-04-16 | Traditional | PDF ↗ |
| K252546 | VantageTM Lumbar Decompression Kit | Allevion Medical, LLC | 2026-03-12 | Traditional | PDF ↗ |
| K253217 | MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700) | Medimaging Integrated Solution, Inc (Miis) | 2025-12-23 | Traditional | PDF ↗ |
| K250795 | PUREVUE FMS | W.O.M. World of Medicine GmbH | 2025-12-05 | Traditional | PDF ↗ |
| K252666 | Articulator Arthroscopic Bur | Joint Preservation Innovations, LLC | 2025-11-21 | Traditional | PDF ↗ |
| K252458 | Kyphoplasty Balloon Dilatation Catheters | Shanghai Lange Medtech Co., Ltd. | 2025-11-03 | Traditional | PDF ↗ |
| K252020 | TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly | Hand Biomechanics Lab, Inc. | 2025-10-15 | Traditional | PDF ↗ |
| K252594 | UltraGuideCTR® image guided soft tissue release system | Sonex Health | 2025-09-29 | Traditional | PDF ↗ |
| K243774 | ELID (Endoscopic Less Invasive Decompression) System | Lesspine Innovations | 2025-08-27 | Traditional | PDF ↗ |
| K241990 | SpineSite Endoscope System | Hydrocision, Inc. | 2025-07-30 | Traditional | PDF ↗ |
| K243602 | Arthrex Spine Endoscope | Arthrex, Inc. | 2025-05-16 | Traditional | PDF ↗ |
| K242417 | VECTR Video Endoscopic Carpal Tunnel Release System | Rafael Medical Devices, LLC | 2024-12-11 | Traditional | PDF ↗ |
| K243020 | MIDASVu | Intravu, Inc. | 2024-12-02 | Traditional | PDF ↗ |
| K233800 | Vertos mild Device Kit (MDK-0002) | Vertos Medical, Inc. | 2024-05-06 | Traditional | PDF ↗ |
| K240535 | Digital ClarusScope System; Digital NeuroPEN System | Clarus Medical, LLC | 2024-04-25 | Traditional | PDF ↗ |
| K233675 | FMS VUE Fluid Management and Tissue Debridement System | DePuy Mitek, Inc. | 2024-02-26 | Traditional | PDF ↗ |
| K233115 | Hawkeye Control Unit with Eyas Endoscope | E Surgical, LLC | 2024-02-06 | Traditional | PDF ↗ |
| K223709 | Kyphoplasty Balloon Catheter | Jiangsu Changmei Medtech Co., Ltd. | 2023-08-16 | Traditional | PDF ↗ |
| K221142 | Kyphoplasty Balloon System | OK Medinet Korea Co., Ltd. | 2023-04-21 | Traditional | PDF ↗ |
| K221919 | DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets | Hemodia Sas | 2023-03-09 | Traditional | PDF ↗ |
| K223406 | SmartRelease Endoscopic Soft Tissue Release System | Microaire Surgical Instruments | 2023-02-02 | Traditional | PDF ↗ |
| K223244 | Pristine Arthroscopic Visualization System | Pristine Surgical | 2022-12-21 | Special | PDF ↗ |
| K222490 | HBL Blade Assembly | Hand Biomechanics Lab, Inc. | 2022-11-14 | Traditional | PDF ↗ |
| K213978 | TELIGEN System | Medos International SARL | 2022-10-18 | Traditional | PDF ↗ |
| K212636 | CORUS Spinal System-X | Providence Medical Technology, Inc. | 2021-10-15 | Traditional | PDF ↗ |
| K212556 | mi-eye 3 needlescope with cannula, mi-tablet 3 | Trice Medical, Inc. | 2021-09-15 | Special | PDF ↗ |
| K211297 | SMARTRELEASE Endoscopic Soft Tissue Release System | Microaire Surgical Instruments | 2021-06-24 | Traditional | PDF ↗ |
| K203480 | DOUBLEFLO system | Hemodia Sas | 2021-04-05 | Traditional | PDF ↗ |
| K202027 | Balex bone Expander System | Taeyeon Medical Co., Ltd. | 2021-02-03 | Traditional | PDF ↗ |
| K193608 | EBERLE Shaver System C3 and Accessories | Eberle GmbH & Co. KG | 2021-01-15 | Traditional | PDF ↗ |
| K203526 | C Scope Visualization System | Cit Ortho | 2021-01-12 | Traditional | PDF ↗ |
| K201113 | Resascope RS-01/B | Advanced Medical Systems Group Srl | 2020-12-21 | Traditional | PDF ↗ |
| K202659 | Stryker Arthroscope | Stryker | 2020-12-01 | Special | PDF ↗ |
| K192921 | Zeos Aqua Vision Pump and tube | Hemodia Sas | 2020-10-09 | Traditional | PDF ↗ |
| K200067 | MectaScope System | Medacta International S.A. | 2020-10-01 | Traditional | PDF ↗ |
| K200763 | Osteo-site Vertebral Balloon | Izi Medical | 2020-08-12 | Traditional | PDF ↗ |
| K201349 | Smith+Nephew Arthroscopes | Smith & Nephew | 2020-07-20 | Traditional | PDF ↗ |
| K200729 | HydroCision SpineJet System | Hydrocision, Inc. | 2020-04-16 | Special | PDF ↗ |
| K191596 | Arcadia Balloon Catheter | Merit Medical Systems, Inc. | 2019-10-09 | Traditional | PDF ↗ |
| K192155 | Smith & Nephew DYONICS 25 Fluid Management System | Smith & Nephew, Inc. | 2019-09-04 | Special | PDF ↗ |
| K191345 | Pegasus System | A.M. Surgical, Inc. | 2019-07-17 | Traditional | PDF ↗ |
| K191259 | Stryker CrossFlow Integrated Arthroscopy Pump | Stryker Corp. | 2019-07-12 | Traditional | PDF ↗ |
| K191594 | Nuvis Battery Arthroscope | Integrated Endoscopy, Inc. | 2019-07-11 | Special | PDF ↗ |
| K191579 | Voyant System | Viseon, Inc. | 2019-07-11 | Special | PDF ↗ |
| K190804 | HydroCision TenJet Device | Hydrocision, Inc. | 2019-06-05 | Traditional | PDF ↗ |
| K182287 | MEDINAUT Plus | Imedicom Co., Ltd. | 2019-04-06 | Traditional | PDF ↗ |
| K190598 | CROSSWAY Spinal Access System | Globus Medical, Inc. | 2019-04-05 | Special | PDF ↗ |
| K190201 | CORUS Spinal System | Providence Medical Technology, Inc. | 2019-03-08 | Special | PDF ↗ |
| K183165 | Pristine Scope | Pristine Surgical | 2019-01-16 | Traditional | PDF ↗ |
| K183470 | Precision Ideal Eyes Arthroscopes | Stryker | 2019-01-07 | Special | PDF ↗ |
| K181752 | Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter) | Stryker Corporation | 2018-12-21 | Traditional | PDF ↗ |
| K182882 | CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control | Conmed Corporation | 2018-11-14 | Special | PDF ↗ |
| K181819 | SMARTRELEASE Endoscopic Soft Tissue Release System | Microaire Surgical Instruments, LLC | 2018-11-06 | Traditional | PDF ↗ |
| K181885 | Voyant System | Viseon, Inc. | 2018-10-02 | Traditional | PDF ↗ |
| K181982 | MIDAScope and Introducer Kit, and MIDASystem | Intravu, Inc. | 2018-08-21 | Traditional | PDF ↗ |
| K180766 | Endiscope, Endiscope Cervical | Elliquence, LLC | 2018-06-11 | Traditional | PDF ↗ |
| K170703 | Single Use Arthroscopic Electrode (with Pencil) | Modern Medical Equipment Manufacturing Limited | 2018-05-31 | Traditional | PDF ↗ |
| K180876 | DTRAX Spinal System | Providence Medical Technology, Inc. | 2018-05-18 | Traditional | PDF ↗ |
| K173311 | ARTHRO-Pump PA304 | W.O.M. World of Medicine GmbH | 2018-05-09 | Traditional | PDF ↗ |
| K180315 | DISKOM | Biopsybell S.R.L. | 2018-03-26 | Traditional | PDF ↗ |
| K172116 | Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter) | Stryker Corporation | 2018-01-25 | Traditional | PDF ↗ |
| K171237 | FMS VUE II Fluid Management and Tissue Debridement System | Medos International SARL | 2018-01-18 | Traditional | PDF ↗ |
| K172092 | Reprocessed Shavers/Burs | Renovo, Inc. | 2017-10-04 | Traditional | PDF ↗ |
| K171794 | Smith & Nephew 25 Fluid Management System | Smith & Nephew, Inc. | 2017-06-27 | Special | PDF ↗ |
| K162070 | JOINIX CANNULAR SYSTEM | Aju Pharm Co., Ltd. | 2017-03-16 | Traditional | PDF ↗ |
| K163037 | Intra medullary endo-transilluminating device (iMET device) | WeMED Bio-Tech, Inc. | 2017-02-17 | Traditional | PDF ↗ |
| K162062 | AVAmax Vertebral Balloon, AVAflex Vertebral Balloon | Stryker Corporation | 2016-11-01 | Traditional | PDF ↗ |
| K161878 | PORTAGE System | Baylis Medical Company, Inc. | 2016-09-26 | Traditional | PDF ↗ |
| K162475 | mi-eye 2, mi-eye 2 monitor | Trice Medical | 2016-09-16 | Special | PDF ↗ |
| K152511 | Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannula | Prosurg, Inc. | 2016-07-11 | Traditional | PDF ↗ |
| K160249 | ULTRA Telescopes | Olympus Winter & Ibe GmbH | 2016-04-21 | Traditional | PDF ↗ |
| K151932 | Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use Tubing | Stryker Corporation | 2016-03-31 | Traditional | PDF ↗ |
| K151268 | SPINAUT-V, SPINAUT-S, SPINAUT-I | Imedicom Co., Ltd. | 2016-03-16 | Traditional | PDF ↗ |
| K153548 | VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM | Visionsense, Ltd. | 2016-02-22 | Traditional | PDF ↗ |
| K151125 | AVAflex Vertebral Balloon System | Care Fusion | 2015-11-24 | Traditional | PDF ↗ |
| K150523 | AVAmax Vertebral Balloon | Care Fusion | 2015-10-29 | Traditional | PDF ↗ |
| K151532 | KYPHON ELEMENT Inflatable Bone Tamp | Medtronic, Inc. | 2015-07-23 | Traditional | PDF ↗ |
| K143705 | NeedleCam HD Visualization System | Biovision Technologies, LLC | 2015-02-20 | Special | PDF ↗ |
| K141557 | HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - CERVICAL, HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - LUMBAR | Gallini Medical Devices, Srl | 2014-12-08 | Traditional | PDF ↗ |
| K141326 | NEEDLE VIEW CH SCOPE KITS | Biovision Technologies, LLC | 2014-10-08 | Traditional | PDF ↗ |
| K141119 | CAMERA ENABLED PROBE | Trice Medical, Inc. | 2014-07-29 | Traditional | PDF ↗ |
| K140903 | NUVIS ARTHROSCOPE | Integrated Endoscopy, Inc. | 2014-07-17 | Traditional | PDF ↗ |
| K141002 | VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM | Visionsense, Ltd. | 2014-06-26 | Traditional | PDF ↗ |
| K133682 | SCHOELLY ARTHROSCOPE | Scholly Fiberoptic GmbH | 2014-06-02 | Traditional | PDF ↗ |
| K133941 | MITEK ARTHROSCOPES | Medos International SARL | 2014-04-18 | Traditional | PDF ↗ |
| K130778 | DISCOSCOPES, CERVICAL ENDOSCOPES | Rz Medizintechnik GmbH | 2014-04-14 | Traditional | PDF ↗ |
| K133018 | OSI Q SYSTEM ARTHROSCOPES | Orthopedic Sciences, Inc. | 2014-02-26 | Traditional | PDF ↗ |
| K133061 | ESPIN SYSTEM | Nlt Spine, Ltd. | 2013-11-27 | Traditional | PDF ↗ |
| K132883 | HEMODIA ARTHROSCOPY PUMP TUBE SETS (HATS) | Hemodia Sas | 2013-11-01 | Traditional | PDF ↗ |
| K131820 | AVAMAX VERTEBRAL BALLOON SYSTEM, 8G, AVAMAX VERTEBRAL BALLOON SYSTEM, 10G, AVAMAX VERTEBRAL BALLOON SYSTEM, 11G | Care Fusion | 2013-10-04 | Traditional | PDF ↗ |
| K131824 | AVAFLEX VERTEBRAL BALLOON SYSTEM | Care Fusion | 2013-10-03 | Traditional | PDF ↗ |
| K131191 | 4MM & 5MM FULL RADIUS BLADE PLUS, 4MM & 5MM BARREL BUR PLUS/4MM BARREL TORNADO BUR PLUS, 4MM & 5MM AGGRESSIVE BLADE PLUS | Depuy Mitek, A Johnson & Johnson Company | 2013-07-22 | Traditional | PDF ↗ |
| K130912 | OMNICUT RESECTION BLADE | Depuy Mitek, A Johnson & Johnson Company | 2013-06-14 | Traditional | PDF ↗ |
| K130430 | IVAS 10MM AND 15MM BALLOON CATHETER | Stryker Corporation | 2013-05-23 | Special | PDF ↗ |
| K130169 | FMS VUE FLUID MANAGMENT SYSTEM, FMS CONNECT INTERFACE CABLE | Depuy Mitek, A Johnson & Johnson Company | 2013-05-01 | Traditional | PDF ↗ |
| K122411 | J-SCOPE SYSTEM | Myelotec | 2013-02-11 | Abbreviated | PDF ↗ |
| K130057 | ESPIN | Nlt Spine, Ltd. | 2013-02-07 | Special | PDF ↗ |
Product code HRX · Class II · Orthopedic. Data: openFDA.