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 3 of 7
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K022578 | ENDIUS FLEXTIP BLADE | Endius, Inc. | 2002-08-23 | Special | PDF ↗ |
| K021748 | ENDIUS ATAVI SYSTEM | Endius, Inc. | 2002-06-26 | Special | PDF ↗ |
| K012667 | REPROCESSED ARTHROSCOPIC SHAPERS | Surgical Instruments Service and Savings, Inc. | 2002-06-03 | Traditional | PDF ↗ |
| K020761 | POWER TEK II | Biomet, Inc. | 2002-04-03 | Special | PDF ↗ |
| K020688 | HYDROCISION ARTHOJET SYSTEM WITH CAUTERY AND TURBOBURR | Hydrocision, Inc. | 2002-04-03 | Special | PDF ↗ |
| K012640 | ELECTROSURGICAL CUTTING AND COAGULATION ACCESSORIES, ELECTROSURGICAL WANDS | Medical Instruments Technology, Inc. | 2002-02-28 | Traditional | PDF ↗ |
| K020083 | TUTA HEALTHCARE ARTHROSCOPY FLUSHING SET, MODEL 80.601 | Tuta Healthcare Pty Limited | 2002-02-12 | Traditional | PDF ↗ |
| K013513 | DEKOMPRESSOR PERCUTANEOUS LUMBAR DISCECTOMY PROBE | Pain Concepts, Inc. | 2002-01-17 | Traditional | PDF ↗ |
| K011202 | MSI BIPOLAR SHEATH | Medical Scientific, Inc. | 2001-12-31 | Traditional | PDF ↗ |
| K011454 | SPINE SCOPE, MODEL 2180 | Clarus Medical, LLC | 2001-12-13 | Traditional | PDF ↗ |
| K013117 | RESECTION ABLATOR | Linvatec Corp. | 2001-11-29 | Traditional | PDF ↗ |
| K012630 | REPROCESSED LINVATEC ARTHROSCOPIC BURS | Alliance Medical, Inc. | 2001-11-09 | Traditional | PDF ↗ |
| K012652 | REPROCESSED DYONICS ARTHROSCOPIC BURS | Alliance Medical Corp. | 2001-11-08 | Traditional | PDF ↗ |
| K012624 | REPROCESSED ARTHROSCOPIC BLADES, ARTHROSCOPIC SHAVERS, SHAVER BLADE, BLADE, LIMITED REUSE BLADE, ARTHROSCOPIC BURS | Medical Instruments Technology, Inc. | 2001-11-08 | Traditional | PDF ↗ |
| K012635 | REPROCESSED STRYKER ARTHROSCOPIC SHAVERS | Alliance Medical Corp. | 2001-11-07 | Traditional | PDF ↗ |
| K012613 | REPROCSSED LINVATEC SHAVERS | Alliance Medical, Inc. | 2001-11-07 | Traditional | PDF ↗ |
| K012605 | REPROCESSED ATHROSCOPICS BURS | Alliance Medical Corp. | 2001-11-07 | Traditional | PDF ↗ |
| K012611 | REPROCESSED DYONICS ARTHROSCOPIC SHAVERS | Alliance Medical, Inc. | 2001-11-07 | Traditional | PDF ↗ |
| K012536 | REPROCESSED POWERED ARTHROSCOPIC ACCESSORIES | Sterilmed, Inc. | 2001-11-02 | Traditional | PDF ↗ |
| K012346 | VANGUARD REPROCESSED ARTHROSCOPIC BLADES | Vanguard Medical Concepts, Inc. | 2001-10-16 | Traditional | PDF ↗ |
| K003198 | VULCAN TAC PROBES, MODEL 911XXX | Oratec Interventions, Inc. | 2001-08-29 | Traditional | PDF ↗ |
| K010345 | KSEA MANHES TAKE-APART BIPOLAR COAGULATING FORCEPS | KARL STORZ Endoscopy-America, Inc. | 2001-08-03 | Traditional | PDF ↗ |
| K003831 | ARTHROSCOPES | Global Endoscopy, Inc. | 2001-07-20 | Traditional | PDF ↗ |
| K011083 | ARTHROCARE SYSTEM 2000 CONTROLLER, CABLE, FOOTSWITCH, POWER CORD & ARTHROCARE ARTHROWAND | Arthrocare Corp. | 2001-06-28 | Traditional | PDF ↗ |
| K010987 | KSEA MINIATURE TELESCOPE AND ACCESSORIES | KARL STORZ Endoscopy-America, Inc. | 2001-06-19 | Traditional | PDF ↗ |
| K010811 | PERC-D SPINEWAND | Arthrocare Corp. | 2001-05-30 | Traditional | PDF ↗ |
| K010677 | XPS 3000 SYSTEM | Medtronic Xomed, Inc. | 2001-05-07 | Traditional | PDF ↗ |
| K003740 | MIASPAS MINITTA ANTERIOR MICRO SURGICAL TRANSTHORACIC APPROACH INSTRUMENTATION | Aesculap, Inc. | 2001-04-27 | Traditional | PDF ↗ |
| K002088 | SHAVER ABLATOR | Linvatec Corp. | 2001-03-06 | Traditional | PDF ↗ |
| K003893 | VULCAN ABLATOR ELECTROSURGICAL PROBES, VULCAN LIGAMENT CHISEL ELECTROSURGICAL PROBES, MODEL 91000X,91002X,91300X | Oratec Interventions, Inc. | 2001-03-01 | Traditional | PDF ↗ |
| K003572 | DYONICS CONTROL RF SYSTEM | Smith & Nephew, Inc. | 2001-02-15 | Traditional | PDF ↗ |
| K003695 | MICROSCOPE-STAINLESS STEEL/FIBER OPTIC: .5-2.6MM MODEL MMD 4500 SERIES AND 2.7-5.0MM MODEL MMD-4700 SERIES | Micro-Medical Devices, Inc. | 2001-02-14 | Traditional | PDF ↗ |
| K010246 | KYPHX INFLATABLE BONE TAMP, SIZE 20/3,MODEL K01A, KYPHX INFLATABLE BONE TAMP, SIZE 15/3, MODEL K02A | Kyphon, Inc. | 2001-02-14 | Traditional | PDF ↗ |
| K010179 | EBI VUECATH SPINAL ENDOSCOPIC SYSTEM | Ebi, L.P. | 2001-02-09 | Special | PDF ↗ |
| K003898 | EBI VUECATH SPINAL ENDOSCOPIC SYSTEM | Ebi, L.P. | 2001-01-04 | Special | PDF ↗ |
| K002931 | METRX SYSTEM | Medtronic Sofamor Danek, Inc. | 2000-11-24 | Traditional | PDF ↗ |
| K002764 | HYDROCISION ARTHROJET SYSTEM WITH CAUTERY AND BURR | Hydrocision, Inc. | 2000-11-24 | Traditional | PDF ↗ |
| K001741 | RADIONICS RF DISC CATHETER ELECTRODE SYSTEM | Radionics, Inc. | 2000-10-23 | Traditional | PDF ↗ |
| K002437 | ENDIUS ENDOSCOPIC ACCESS SYSTEM | Endius, Inc. | 2000-10-02 | Traditional | PDF ↗ |
| K001918 | KSEA PERCUTANEOUS FORAMINOSCOPY SET | KARL STORZ Endoscopy-America, Inc. | 2000-09-19 | Traditional | PDF ↗ |
| K002040 | FMS SOLO | Future Medical Systems, Inc. | 2000-09-11 | Traditional | PDF ↗ |
| K002402 | VAPR TC ELECTRODE FOR USE WITH VAPR II ELECTROSURGICAL SYSTEM | Mitek Products | 2000-08-31 | Special | PDF ↗ |
| K002008 | SURGICAL DYNAMICS SPINAL RETRACTOR | United States Surgical, A Division of Tyco Healthc | 2000-08-16 | Traditional | PDF ↗ |
| K001226 | SMITH + NEPHEW RF ARTHROSCOPIC WAND SYSTEM | Smith & Nephew, Inc. | 2000-06-26 | Traditional | PDF ↗ |
| K000691 | VULCAN ELECTROSURGICAL PROBES: VULCAN MICRO LIGAMENT CHISELS, VULCAN LIGAMENT CHISELS, VULCAN EFLEX LIGAMENT CHISELS | Oratec Interventions, Inc. | 2000-05-04 | Traditional | PDF ↗ |
| K000198 | CORTEK ARTHROSCOPE | Cortek Endoscopy, Inc. | 2000-04-11 | Traditional | PDF ↗ |
| K000046 | KNIGHT ENDOSCOPIC SPINE SYSTEM (KESS) | Richard Wolf Medical Instruments Corp. | 2000-03-30 | Traditional | PDF ↗ |
| K994363 | INSTRUMENTS FOR MINIMALLY INVASIVE SPINAL SURGERY (MISS) | Richard Wolf Medical Instruments Corp. | 2000-03-06 | Traditional | PDF ↗ |
| K994425 | MODIFICATION TO ENDOSCOPIC SPINAL ACCESS SYSTEM | Endius, Inc. | 2000-02-16 | Traditional | PDF ↗ |
| K000153 | ARTHRO-SURGIMAT-A103 | W.O.M. World of Medicine GmbH | 2000-02-08 | Special | PDF ↗ |
| K991656 | AED ARTHROSCOPE | National Advanced Endoscopy Devices, Inc. | 1999-12-02 | Traditional | PDF ↗ |
| K993540 | ENDOSPINE OPERATING TUBE AND TELESCOPE BRIDGE | KARL STORZ Endoscopy-America, Inc. | 1999-11-22 | Traditional | PDF ↗ |
| K993021 | METRX SYSTEM | Surgical Navigation Technologies, Inc. | 1999-11-10 | Traditional | PDF ↗ |
| K992621 | ADI 9000/9001 ARTHROSCOPE AND ACCESSORIES | Advanced Diagnostics & Interventions | 1999-11-08 | Traditional | PDF ↗ |
| K992583 | MASS (MICRO-ACCESS SPINE SYSTEM) | Omni-Tract Surgical, Div. Minn. Scientific, Inc. | 1999-10-29 | Traditional | PDF ↗ |
| K993009 | HYDROCISION ARTHROJET SYSTEM WITH CAUTERY | Hydrocision, Inc. | 1999-10-25 | Traditional | PDF ↗ |
| K990397 | FLEXIBLE FIBERSCOPES & ACCESSORIES | Richard Wolf Medical Instruments Corp. | 1999-10-25 | Traditional | PDF ↗ |
| K992782 | NUVASIVE SPINAL ARTHROSCOPE, MODELS 0, 30 AND 70 DEGREES | Nuvasive, Inc. | 1999-10-05 | Traditional | PDF ↗ |
| K990324 | NUVASIVE GUIDED SPINAL ARTHROSCOPY SYSTEM | Nuvasive, Inc. | 1999-10-05 | Traditional | PDF ↗ |
| K992876 | VAPR 2.3 MM SIDE EFFECT ELECTRODE FOR USE WITH VAPR SYSTEM | Mitek Products | 1999-09-24 | Special | PDF ↗ |
| K992474 | ARTHROSCOPE / MEDIFIX INC. | Medifix, Inc. | 1999-09-23 | Traditional | PDF ↗ |
| K991794 | ENDOSCOPIC SPINAL ACCESS SYSTEM | Endius, Inc. | 1999-08-13 | Traditional | PDF ↗ |
| K984304 | RIWO DRIVE GENERATOR | Richard Wolf Medical Instruments Corp. | 1999-08-12 | Traditional | PDF ↗ |
| K992040 | FLEXISCOPE II ARTHROSCOPES AND ACCESSORIES | Fiber Imaging Technologies, Inc. | 1999-08-06 | Traditional | PDF ↗ |
| K990524 | E9000 SYSTEM | Linvatec Corp. | 1999-07-15 | Traditional | PDF ↗ |
| K990911 | MTP ARTHROPUMP DISPOSABLE TUBING SET | Mtp Medical Technical Promotion GmbH | 1999-06-03 | Traditional | PDF ↗ |
| K991051 | KSEA EPIDUROSCOPE | KARL STORZ Endoscopy-America, Inc. | 1999-06-01 | Traditional | PDF ↗ |
| K990459 | EBI VUECATH ENDOSCOPIC SYSTEN | Electro-Biology, Inc. | 1999-04-23 | Traditional | PDF ↗ |
| K983652 | ABLATOR ELECTRODE | Linvatec Corp. | 1999-03-23 | Traditional | PDF ↗ |
| K990443 | ARTHRO-SURGIMAT-2000 ECU | W.O.M. World of Medicine GmbH | 1999-02-26 | Special | PDF ↗ |
| K983144 | FLEXPOSURE RETRACTOR | Endius, Inc. | 1999-02-24 | Traditional | PDF ↗ |
| K983142 | KSEA C-MOUNT ARTHROSCOPES | Karl Storz Endoscopy | 1998-12-07 | Traditional | PDF ↗ |
| K983910 | ARTHRO-SURGIMAT-1500 | W.O.M. World of Medicine GmbH | 1998-11-25 | Special | PDF ↗ |
| K983384 | DCI ENDOSCOPE | KARL STORZ Endoscopy-America, Inc. | 1998-11-25 | Traditional | PDF ↗ |
| K983025 | XOMED FEATHERTOUCH XPS POWER RASP ATTACHMENT | Xomed, Inc. | 1998-11-06 | Traditional | PDF ↗ |
| K982133 | OLYMPUS ENDOSCOPIC SYSTEM LUMBAR HERNIA DISCECTOMY AND ITS ANCILLARY EQUIPMENT | The Olympus Optical Co. | 1998-10-22 | Traditional | PDF ↗ |
| K982484 | EBI VUECATH ENDOSCOPIC SPINAL SYSTEM | Electro-Biology, Inc. | 1998-10-08 | Traditional | PDF ↗ |
| K982375 | STRYKER HIP ARTHOROSCOPY SET | Stryker Endoscopy | 1998-10-02 | Traditional | PDF ↗ |
| K982266 | HYDROCISION ARTHROJET SYSTEM | Hydrocision, Inc. | 1998-09-25 | Traditional | PDF ↗ |
| K981636 | INTEGRATED DRIVE/PUMP SYSTEM | Linvatec Corp. | 1998-08-20 | Traditional | PDF ↗ |
| K980734 | MYELOTEC VIDEO GUIDED CATHETER | Myelotec, Inc. | 1998-08-11 | Traditional | PDF ↗ |
| K981251 | KYPHON INFLATABLE BONE TAMP | Kyphon, Inc. | 1998-07-02 | Traditional | PDF ↗ |
| K981269 | UNIVERSAL DRIVE SYSTEM | Linvatec Corp. | 1998-06-24 | Traditional | PDF ↗ |
| K981156 | DYONICS INTELIJET INFLOW/OUTFLOW CANNULA | Smith & Nephew, Inc. | 1998-05-20 | Traditional | PDF ↗ |
| K973405 | YEUNG ENDOSCOPIC SPINE SYSTEM | Richard Wolf Medical Instruments Corp. | 1998-03-13 | Traditional | PDF ↗ |
| K974579 | PERCSCOPE MODEL 2600 | Clarus Medical Systems, Inc. | 1998-02-18 | Traditional | PDF ↗ |
| K973499 | XPS STRAIGHTSHOT MICROBRIDER SYSTEM OR TREBAY SHAVER SYSTEM | Xomed, Inc. | 1998-01-30 | Traditional | PDF ↗ |
| K971781 | GREATBATCH SCIENTIFIC MR COMPATIBLE ARTHROSCOPES AND SMALL JOINT ARTHROSCOPES | Wilson Greatbatch Technologies, Inc. | 1997-11-21 | Traditional | PDF ↗ |
| K971649 | KSEA ARTHROPUMP PLUS | KARL STORZ Endoscopy-America, Inc. | 1997-10-29 | Traditional | PDF ↗ |
| K973195 | TOTAL PERFORMANCE SYSTEM SHAVER | Stryker Endoscopy | 1997-10-24 | Traditional | PDF ↗ |
| K972768 | BLACKSTONE MEDICAL, INC. LAPAROSCOPIC DISC REMOVAL SYSTEM | Blackstone Medical, Inc. | 1997-09-25 | Traditional | PDF ↗ |
| K970511 | DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES | Smith & Nephew, Inc. | 1997-08-12 | Traditional | PDF ↗ |
| K971996 | MEDIVISION ARTHROSCOP | Medivision Scope Service Center, Inc. | 1997-07-31 | Traditional | PDF ↗ |
| K971676 | LIMITED REUSE ENDOSCOPIC BLADES | Smith & Nephew, Inc. | 1997-06-27 | Traditional | PDF ↗ |
| K971083 | ARTHROSCOPE | Electro-Biology, Inc. | 1997-06-23 | Traditional | PDF ↗ |
| K971059 | UNIVERSAL DRIVE SYSTEM | Linvatec Corp. | 1997-06-18 | Traditional | PDF ↗ |
| K971253 | VARIOUS ARTHROSCOPES, ENDOSCOPIC BLADES, MANUAL INSTRUMENTS | Smith & Nephew, Inc. | 1997-06-13 | Traditional | PDF ↗ |
| K970642 | TENOSCOPE | Luxtec Corp. | 1997-05-21 | Traditional | PDF ↗ |
| K970562 | TENOSNARE | Luxtec Corp. | 1997-05-14 | Traditional | PDF ↗ |
| K970055 | KARL STORZ MULTIDRIVE II MINI SHAVER FOR ARTHROSCOPY | KARL STORZ Endoscopy-America, Inc. | 1997-03-05 | Traditional | PDF ↗ |
Product code HRX · Class II · Orthopedic. Data: openFDA.