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 5 of 7
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K950130 | MICRO-ENDO(TM) INSTRUMENTS | Sofamor Danek USA,Inc. | 1995-05-01 | Traditional | PDF ↗ |
| K940144 | CLARUS PHOENIX ENDOSCOPE | Clarus Medical Systems, Inc. | 1995-04-25 | Traditional | PDF ↗ |
| K941188 | CLARUS NEURO ENDOSCOPE (MODEL 2230) | Clarus Medical Systems, Inc. | 1995-04-25 | Traditional | PDF ↗ |
| K941709 | ACUFEX ARTHROSCOPIC DISCECTOMY SYSTEMS | Acufex Microsurgical, Inc. | 1995-04-14 | Traditional | PDF ↗ |
| K945973 | FMS ARTHROSCOPY CANNULA | Future Medical Systems, Inc. | 1995-03-22 | Traditional | PDF ↗ |
| K946313 | TIBIAL ROUTERS, FEMORAL ROUTERS AND TUBE GRAFT SIZER | Smith and Nephew Donjoy, Inc. | 1995-03-17 | Traditional | PDF ↗ |
| K943450 | ARTHROCARE ARTHROSCOPIC ELECTROSURGERY SYSTEM MODEL 970 | Arthrocare Corp. | 1995-03-13 | Traditional | PDF ↗ |
| K943937 | MANUAL INSTRUMENTS | Pantheon Surgical Products | 1995-03-06 | Traditional | PDF ↗ |
| K944210 | ARTHROSCOPE ACCESSORIES | Stryker Endoscopy | 1995-02-14 | Traditional | PDF ↗ |
| K943426 | ARTHROSCOPE,RIGID ROD-LENS DIAGNOSTIC ENDOSCOPE | Schoelly Technologies, Inc. | 1995-02-01 | Traditional | PDF ↗ |
| K944842 | ARTHROSCOPE | 5 Star Medical, Inc. | 1995-01-24 | Traditional | PDF ↗ |
| K941651 | CTS RELIEF KIT | Linvatec Corp. | 1995-01-18 | Traditional | PDF ↗ |
| K942298 | THE KARL STORZ ARTHROPUMP | KARL STORZ Endoscopy-America, Inc. | 1995-01-17 | Traditional | PDF ↗ |
| K943943 | TRANSTIBIAL ACL DISPOSABLES KIT | Arthrex, Inc. | 1994-12-20 | Traditional | PDF ↗ |
| K940230 | ENDOSCOPIC MORTONS NEUROMA INSTRUMENTS | Instratek, Inc. | 1994-12-12 | Traditional | PDF ↗ |
| K943154 | KARL STORTZ OBTURATOR)SHARP/BLUNT)/CANNULAE/SHEATHS | KARL STORZ Endoscopy-America, Inc. | 1994-12-06 | Traditional | PDF ↗ |
| K943323 | STRYKER SURGICAL INSTRUMENTS AND ACCESSORIES | Stryker Corp. | 1994-11-28 | Traditional | PDF ↗ |
| K943628 | ARTHROSCOPE | Electro Fiberoptics Corp. | 1994-11-22 | Traditional | PDF ↗ |
| K940287 | MENISCAL SUTURE INSTRUMENTARIUM | Richard Wolf Medical Instruments Corp. | 1994-11-22 | Traditional | PDF ↗ |
| K943676 | DANEKSCOPE OPTI-PROBE | Danek Medical, Inc. | 1994-11-21 | Traditional | PDF ↗ |
| K943666 | ENVISION ARTHROSCOPY VISUALIZATION SYSTEM | Envision Surgical System, Inc. | 1994-11-17 | Traditional | PDF ↗ |
| K942427 | ENVISION ARTHROSCOPE, CANNULA,TROCAR, OBTURATOR, AND PROBE | Envision Surgical System, Inc. | 1994-11-17 | Traditional | PDF ↗ |
| K941333 | SE5 ARTHROSCOPY SYTEM | Stryker Endoscopy | 1994-11-10 | Traditional | PDF ↗ |
| K942081 | ENVISION ARTHROSCOPY SYSTEM | Envision Surgical System, Inc. | 1994-11-09 | Traditional | PDF ↗ |
| K943985 | LIMITED REUSE BLADES | Linvatec Corp. | 1994-11-07 | Traditional | PDF ↗ |
| K940847 | ENDOSCOPIC PLANTAR FASCIA KIT | Citation Medical Corp. | 1994-10-11 | Traditional | PDF ↗ |
| K934707 | GALILEO ARTHROSCOPES | Galileo Electro-Optics Corp. | 1994-10-07 | Traditional | PDF ↗ |
| K941718 | 3M FLUID CONTROL SYSTEM 8300 CASSETTE LOAD | 3M Medical Products Group | 1994-10-07 | Traditional | PDF ↗ |
| K941388 | 3M FLUID IRRIGATION SYSTEM | 3M Healthcare | 1994-10-07 | Traditional | PDF ↗ |
| K940913 | SPINE-TECH LAPAROSCOPIC INSTRUMENTATION SYSTEM | Spine-Tech, Inc. | 1994-10-04 | Traditional | PDF ↗ |
| K942101 | 4-LEAD IRRIGATION SET | Douglas Medical Products Corp. | 1994-09-30 | Traditional | PDF ↗ |
| K940290 | ACUFEX ACL SHEATH FOR INTERFERENCE SCREWS | Acufex Microsurgical, Inc. | 1994-09-28 | Traditional | PDF ↗ |
| K942846 | ACUFEX(R) ENDO-FEMORAL AIMER | Acufex Microsurgical, Inc. | 1994-09-28 | Traditional | PDF ↗ |
| K942079 | MANUAL SURGICAL INSTRUMENTS | Acufex Microsurgical, Inc. | 1994-09-28 | Traditional | PDF ↗ |
| K942834 | ACUFEX UNI-CUT 4. OMM CARPAL TUNNEL CANNULA | Acufex Microsurgical, Inc. | 1994-09-28 | Traditional | PDF ↗ |
| K941036 | CURVED ROTATABLE DISPOSABLE ARTHROSCOPIC SURGERY BLADES | Smith & Nephew, Inc. | 1994-09-28 | Traditional | PDF ↗ |
| K941964 | LMT ARTHROSCOPIC SUTURING INSTRUMENTS | Li Medical Technologies, Inc. | 1994-09-28 | Traditional | PDF ↗ |
| K935617 | ARTHRO-FLO IRRIGATION SYSTEM MODIFICATION | Davol Inc., Sub. C. R. Bard, Inc. | 1994-09-16 | Traditional | PDF ↗ |
| K941273 | INNOVASIVE ARTHROSCOPIC ROC SUTURE BONE FASTENER | Innovasive Devices, Inc. | 1994-09-16 | Traditional | PDF ↗ |
| K941691 | REVO ROTATOR CUFF REPAIR SYSTEM | Linvatec Corp. | 1994-09-06 | Traditional | PDF ↗ |
| K940234 | CARPAL TUNNEL SYSTEM | Richard Wolf Medical Instruments Corp. | 1994-08-11 | Traditional | PDF ↗ |
| K936280 | GALILEO ARTHROSCOPES | Galileo Electro-Optics Corp. | 1994-07-12 | Traditional | PDF ↗ |
| K940222 | SMITH AND NEPHEW SPINE DEFLECTING FORCEPS | Smith & Nephew, Inc. | 1994-06-29 | Traditional | PDF ↗ |
| K940554 | TNCO, INC. ARTHROSCOPIC SURGICAL INSTRUMENTS | Tnco, Inc. | 1994-06-29 | Traditional | PDF ↗ |
| K932099 | ACUMED FLEXIBLE CANNULA | Acu Med, Inc. | 1994-06-28 | Traditional | PDF ↗ |
| K932090 | ACUFEX DISPOSABLE MENISCAL CANNULA | Acufex Microsurgical, Inc. | 1994-06-28 | Traditional | PDF ↗ |
| K940090 | ARTHROSCOPE | Richard Wolf Medical Instruments Corp. | 1994-06-03 | Traditional | PDF ↗ |
| K940515 | POLY BLADES | Linvatec Corp. | 1994-05-26 | Traditional | PDF ↗ |
| K941269 | GORE SMOOTHER II AND GORE BPTB | W. L. Gore & Associates, Inc. | 1994-05-19 | Traditional | PDF ↗ |
| K936213 | ARTHROSCOPES AND ACCESSORIES | Micro-Medical Devices, Inc. | 1994-05-18 | Traditional | PDF ↗ |
| K940981 | ACUFEX LINEAR/ROTARY INSTRUMENTS | Acufex Microsurgical, Inc. | 1994-05-16 | Traditional | PDF ↗ |
| K940985 | ACUFEX(R) ARTHROPLASTY INSTRUMENTS | Acufex Microsurgical, Inc. | 1994-05-16 | Traditional | PDF ↗ |
| K941364 | ACUFEX T-FIX ROTATOR CUFF GUIDE SYSTEMS | Acufex Microsurgical, Inc. | 1994-05-16 | Traditional | PDF ↗ |
| K940481 | ACUFEX ARTHROSCOPIC SHOULDER GUIDE SYSTEM | Acufex Microsurgical, Inc. | 1994-05-06 | Traditional | PDF ↗ |
| K935221 | STRYKER ARTHROSCOPIC MANUAL SURGICAL INSTRUMENTS | Stryker Endoscopy | 1994-04-28 | Traditional | PDF ↗ |
| K931323 | MOUNTABLE KNIFE | Esco Medical | 1994-04-28 | Traditional | PDF ↗ |
| K940506 | ACUFEX ARTHROSCOPIC SUTURE CUTTER | Acufex Microsurgical, Inc. | 1994-04-26 | Traditional | PDF ↗ |
| K940623 | ACUFEX SURETAC IXC SYSTEMS | Acufex Microsurgical, Inc. | 1994-04-26 | Traditional | PDF ↗ |
| K933576 | ARTHROSCOPE, DISPOSABLE | United States Surgical, A Division of Tyco Healthc | 1994-04-21 | Traditional | PDF ↗ |
| K921119 | ARTHREX ARTHROSCOPE | Arthrex, Inc. | 1994-04-15 | Traditional | PDF ↗ |
| K940075 | SHAVER BLADE SET | Arthrex, Inc. | 1994-04-15 | Traditional | PDF ↗ |
| K934379 | LINVATEC POWERLINK SURGICAL SHAVING SYSTEM | Linvatec Corp. | 1994-04-15 | Traditional | PDF ↗ |
| K931076 | ARTHOSCOPE AND ACCESSORIES | Meditron Devices, Inc. | 1994-03-31 | Traditional | PDF ↗ |
| K931109 | NUCLEOTOME E KIT | Surgical Dynamics, Inc. | 1994-03-29 | Traditional | PDF ↗ |
| K922519 | MOD. PERCUTANEOUS ARTHROSCOPIC MICRO DISCECTOMY | Smith & Nephew, Inc. | 1994-03-29 | Traditional | PDF ↗ |
| K934332 | SURGICAL INSTRUMENTS, FORCEPS & GRASPERS, PROBES & CURETTES | Friatec Medical Inc., USA | 1994-03-25 | Traditional | PDF ↗ |
| K932869 | ARTHROPLANE | Synvasive Technology, Inc. | 1994-03-25 | Traditional | PDF ↗ |
| K940454 | GRASPING FORCEPS, PUNCHES, SCISSORS | L.A.S.E.R., Inc. | 1994-03-25 | Traditional | PDF ↗ |
| K933470 | ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM | Kinetix Instruments | 1994-03-25 | Traditional | PDF ↗ |
| K934720 | AUTO SUTURE DISPOSABLE ARTHROSCOPIC TROCAR AND SLEEVE | United States Surgical, A Division of Tyco Healthc | 1994-03-25 | Traditional | PDF ↗ |
| K933638 | ACUMED CARPAL TUNNEL RELEASE KIT | Acu Med, Inc. | 1994-03-24 | Traditional | PDF ↗ |
| K933070 | ARTHTOTEK PRECISION HAND INSTRUMENTATION | Biomet, Inc. | 1994-03-24 | Traditional | PDF ↗ |
| K934401 | ARTHROTEK CANNULA SYSTEM | Biomet, Inc. | 1994-03-24 | Traditional | PDF ↗ |
| K934181 | ACUFEX ADJUSTABLE-LENGTH CANNULA | Acufex Microsurgical, Inc. | 1994-03-23 | Traditional | PDF ↗ |
| K936206 | GORE SMOOTHER CRUCIAL TOOL | W. L. Gore & Associates, Inc. | 1994-03-23 | Traditional | PDF ↗ |
| K932460 | ACUFEX MENISCAL RASPS | Acufex Microsurgical, Inc. | 1994-03-22 | Traditional | PDF ↗ |
| K932718 | ACUFEX METAL ACL CANNULA | Acufex Microsurgical, Inc. | 1994-03-21 | Traditional | PDF ↗ |
| K933949 | DISPOSABLE ARTHROSCOPIC ACCESSORY | United States Surgical, A Division of Tyco Healthc | 1994-03-18 | Traditional | PDF ↗ |
| K930152 | ARTHREX TIBIAL TUNNEL CANNULA | Arthrex, Inc. | 1994-03-11 | Traditional | PDF ↗ |
| K925160 | ARTHRO FMS 4 | Orthoconcept, Inc. | 1994-02-17 | Traditional | PDF ↗ |
| K934270 | ACUFEX ARTHROSCOPE | Acufex Microsurgical, Inc. | 1994-02-14 | Traditional | PDF ↗ |
| K934299 | DYONICS DISPOSABLE ARTHROSCOPIC SURGERY BLADES MODIFICATION | Smith & Nephew Dyonics, Inc. | 1994-02-14 | Traditional | PDF ↗ |
| K926212 | ARTHREX INSTRUMENTS ( HIP ) | Arthrex, Inc. | 1994-01-31 | Traditional | PDF ↗ |
| K926303 | ARTHREX INSTRUMENTS (WRIST) | Arthrex, Inc. | 1994-01-26 | Traditional | PDF ↗ |
| K931621 | ACUFEX PRO-PAC AND ISO-PAC | Acufex Microsurgical, Inc. | 1994-01-21 | Traditional | PDF ↗ |
| K923514 | CLARUS SERIES 2100 ENDOSCOPE | Clarus Medical Systems, Inc. | 1994-01-07 | Traditional | PDF ↗ |
| K924016 | SYMBIOSIS REUSABLE ARTHROSCOPIC SURGICAL INST. | Symbiosis Corp. | 1993-12-06 | Traditional | PDF ↗ |
| K922486 | DANEK TISSUE CUTTING AND REMOVAL SYSTEM | Sofamor Danek Mfg., Inc. | 1993-10-12 | Traditional | PDF ↗ |
| K922321 | OMNI ARTHROSCOPE | Expanded Optics, Inc. | 1993-08-03 | Traditional | PDF ↗ |
| K925226 | SIGHT-PLUS ARTHROSCOPE | American Medical Concepts, Inc. | 1993-07-28 | Traditional | PDF ↗ |
| K921985 | ARTHROSCOPE & ACCESSORIES | Optimed Technologies, Inc. | 1993-06-29 | Traditional | PDF ↗ |
| K923069 | RESTORE TUNNEL PLUG | Depuy, Inc. | 1993-06-08 | Traditional | PDF ↗ |
| K924773 | BURTON H- BASE TABLE - MODEL 1990 | R.H. Burton Co. | 1993-06-07 | Traditional | PDF ↗ |
| K924494 | CITSCOPE, BENDABLE -- MODIFICATION | Citation Medical Corp. | 1993-05-26 | Traditional | PDF ↗ |
| K925573 | ACUFEX T-BAR | Acufex Microsurgical, Inc. | 1993-05-05 | Traditional | PDF ↗ |
| K925083 | ENDOTRAK SYSTEM | Instratek, Inc. | 1993-04-27 | Traditional | PDF ↗ |
| K925577 | DANEK TISSUE RESECTING SYSTEM | Sofamor Danek Mfg., Inc. | 1993-04-08 | Traditional | PDF ↗ |
| K924144 | ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM (CTR) | Davol, Inc. | 1993-04-08 | Traditional | PDF ↗ |
| K911729 | DANEKSCOPE AND ACCESSORIES | Danek Medical, Inc. | 1993-04-05 | Traditional | PDF ↗ |
| K924017 | SYMBIOSIS DISPOSABLE ARTHROSCOPIC SURGICAL INST. | Symbiosis Corp. | 1993-03-16 | Traditional | PDF ↗ |
Product code HRX · Class II · Orthopedic. Data: openFDA.