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 6 of 7
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K926111 | ARTHROSCOPIC KNEE INSTRUMENTS | Arthrex, Inc. | 1993-03-16 | Traditional | PDF ↗ |
| K926193 | ARTHREX INSTRUMENTS (SHOULDER GP. 1) | Arthrex, Inc. | 1993-03-16 | Traditional | PDF ↗ |
| K925996 | ARTHROSCOPIC ACL CANNULATED DRILLS AND SLEEVES | Arthrex, Inc. | 1993-03-16 | Traditional | PDF ↗ |
| K926062 | ARTHROSCOPIC KNEE INSTRUMENTS | Arthrex, Inc. | 1993-03-16 | Traditional | PDF ↗ |
| K925456 | ARTHROSCOPIC INSTRUMENTS | Arthrex, Inc. | 1993-03-04 | Traditional | PDF ↗ |
| K925458 | ARTHREX RING CURETTE | Arthrex, Inc. | 1993-03-04 | Traditional | PDF ↗ |
| K925954 | ARTHREX INSTRUMENTS (BASIC) | Arthrex, Inc. | 1993-03-04 | Traditional | PDF ↗ |
| K925457 | ARTHREX BAYONET KNIFE | Arthrex, Inc. | 1993-03-04 | Traditional | PDF ↗ |
| K925986 | ARTHROSCOPIC ACL DRILL SYSTEM | Arthrex, Inc. | 1993-03-04 | Traditional | PDF ↗ |
| K925995 | ARTHREX INSTRUMENTS (KNEE, GP 3) | Arthrex, Inc. | 1993-03-04 | Traditional | PDF ↗ |
| K925814 | ARTHREX INSTRUMENTS (BASIC) | Arthrex, Inc. | 1993-03-04 | Traditional | PDF ↗ |
| K925884 | ARTHROSCOPIC RETRACTORS AND GRASPERS | Arthrex, Inc. | 1993-03-04 | Traditional | PDF ↗ |
| K923142 | ARTHREX PLUS | Arthrex, Inc. | 1993-02-09 | Traditional | PDF ↗ |
| K923525 | NUCLEOTOME 3.5 MM AUTOMATED PERCUTANEOUS LUMBAR | Surgical Dynamics, Inc. | 1993-02-09 | Traditional | PDF ↗ |
| K922890 | ARTHREX KNEE ARTHROSCOPIC SURGERY ACCESSORIES | Arthrex, Inc. | 1993-02-08 | Traditional | PDF ↗ |
| K925455 | ARTHREX ATRAUMATIC MINI-GRASPER | Arthrex, Inc. | 1993-02-08 | Traditional | PDF ↗ |
| K925437 | ACUFEX CANNULATED BONE TUNNEL PLUGS | Cufex Microsurgical, Inc. | 1992-12-24 | Traditional | PDF ↗ |
| K921823 | ARTHREX ARTHROSCOPY ICE BLADE | Arthrex, Inc. | 1992-10-15 | Traditional | PDF ↗ |
| K922557 | ACUFEX ARTHROSCOPIC CARPAL TUNNEL RELEASE KIT | Acufex Microsurgical, Inc. | 1992-09-17 | Traditional | PDF ↗ |
| K920454 | CLEARTRAC CANNULA | Acufex Microsurgical, Inc. | 1992-09-16 | Traditional | PDF ↗ |
| K922391 | ENDOSCOPIC CARPAL TUNNEL INSTRUMENTS | Instratek, Inc. | 1992-08-18 | Traditional | PDF ↗ |
| K922318 | DOUGLAS MEDICAL PRODUCTS, INC. IRRIGATION SET | Douglas Medical Products Corp. | 1992-08-10 | Traditional | PDF ↗ |
| K922144 | CITSCOPE (MODEL EXTENSIONS) | Citation Medical Corp. | 1992-08-05 | Traditional | PDF ↗ |
| K921692 | INTEGRATED VIDEO SYSTEM | Citation Medical Corp. | 1992-07-01 | Traditional | PDF ↗ |
| K920800 | INTEGRATED ENDOSCOPY SYSTEM 1000 | Biomet, Inc. | 1992-06-30 | Traditional | PDF ↗ |
| K914963 | SMITH & NEPHEW DYONICS TMJ ARTHROSCOPY INFLOW SET | Smith & Nephew Dyonics, Inc. | 1992-06-04 | Traditional | PDF ↗ |
| K915721 | MODEL AR-6300 INFUSION PUMP | Arthrex, Inc. | 1992-03-19 | Traditional | PDF ↗ |
| K913401 | SUCTION CONTROL FOOTSWITCH WITH SPEED CONTROL | Smith & Nephew Dyonics, Inc. | 1992-03-06 | Traditional | PDF ↗ |
| K914559 | SMALL JOINT SYSTEM | Smith & Nephew Dyonics, Inc. | 1992-02-18 | Traditional | PDF ↗ |
| K901692 | DANEK SPINALSCOPE | Danek Medical, Inc. | 1992-02-14 | Traditional | PDF ↗ |
| K914282 | NUCLEOTOME(R) II (VERSION2) TISSUE ASPIRA/CUTTER | Surgical Dynamics, Inc. | 1991-12-19 | Traditional | PDF ↗ |
| K913145 | NUCLEOTOME TISSUE ASPIRATOR/CUTTER | Surgical Dynamics, Inc. | 1991-12-19 | Traditional | PDF ↗ |
| K912099 | 3M FLUID CONTROL SYSTEM SMALL JOINT COPS CANNULA | 3M Company | 1991-12-09 | Traditional | PDF ↗ |
| K911974 | PGK STEREOTACTIC DEVICE | Northern Virginia Radiology and Nuclear Medicine | 1991-11-05 | Traditional | PDF ↗ |
| K913028 | ARTHRO-FLOW IRRIGATION 2 SYSTEM | Davol, Inc. | 1991-10-10 | Traditional | PDF ↗ |
| K912957 | CONCEPT MICROMILL | Concept, Inc. | 1991-10-04 | Traditional | PDF ↗ |
| K911296 | OPTICAL CATHETER ARTHROSCOPE | Medical Dynamics, Inc. | 1991-09-24 | Traditional | PDF ↗ |
| K913347 | PALMER ARCH SUPPRESSOR | Smith & Nephew Dyonics, Inc. | 1991-09-18 | Traditional | PDF ↗ |
| K912453 | INTELIJET TM FLUID MANAGEMENT SYSTEM | Smith & Nephew Dyonics, Inc. | 1991-08-26 | Traditional | PDF ↗ |
| K912205 | MICRO-AIRE ARTHROS SURG BLADES-VARIOUS DYS PROD NO | Microaire | 1991-08-16 | Traditional | PDF ↗ |
| K912206 | MICRO-AIRE ARTHROS SURG BLADES-VARIOUS CO PROD NO. | Microaire | 1991-08-16 | Traditional | PDF ↗ |
| K912871 | INSIDE JOB | 3M Health Care, Ltd. | 1991-08-09 | Traditional | PDF ↗ |
| K912108 | BLADES, WHISKERS, TRIMMERS, CUTTERS, AND BURS | Microaire Advanced Surgical Products | 1991-07-02 | Traditional | PDF ↗ |
| K911205 | ARTHROSCOPY INSTRUMENT CANNULA | Davol, Inc. | 1991-06-17 | Traditional | PDF ↗ |
| K910858 | STRYKER ARTHROSCOPIC INFUSION PUMP | Stryker Corp. | 1991-05-23 | Traditional | PDF ↗ |
| K910587 | MINISCOPE | Citation Medical Corp. | 1991-05-13 | Traditional | PDF ↗ |
| K910674 | FLEXMEDICS MALLEABLE CANNULA | Flexmedics | 1991-04-12 | Traditional | PDF ↗ |
| K911300 | MICROSURGICAL INSTRUMENTS | Danek Medical, Inc. | 1991-04-05 | Traditional | PDF ↗ |
| K905014 | AMSET PLD SYSTEM | Advanced Med/Surg, Inc. | 1991-04-01 | Traditional | PDF ↗ |
| K910164 | ORTHOCONCEPT ARTHROSCOPIC PUMP | Orthoconcept, Inc. | 1991-03-27 | Traditional | PDF ↗ |
| K905785 | ARTHRO-FMS-3/IRRIGATION SETS (VARIOUS) | Orthoconcept, Inc. | 1991-03-26 | Traditional | PDF ↗ |
| K904859 | MOTOR DRIVEN EXTIRPATION INSTRUMENTS | Aesculap, Inc. | 1991-03-15 | Traditional | PDF ↗ |
| K904465 | FLEXIBLE ARTHROSCOPE | Intramed Laboratories, Inc. | 1990-12-20 | Traditional | PDF ↗ |
| K904284 | ARTHROSCOPIC SURGICAL BLADE | Smith & Nephew Dyonics, Inc. | 1990-12-05 | Traditional | PDF ↗ |
| K904479 | SURGICAL INST.:1030,1010,1011,1012,1013,1014,1015 | Percutaneous Technologies | 1990-11-02 | Traditional | PDF ↗ |
| K902778 | SURGICAL DYNAMICS NUCLEOTOME II TISSUE ASPIR/CUTER | Surgical Dynamics, Inc. | 1990-10-30 | Traditional | PDF ↗ |
| K904720 | POWERCUT SURGICAL SYSTEM, BLADES, AND ACCESSORIES | Baxter Healthcare Corp | 1990-10-26 | Traditional | PDF ↗ |
| K900613 | SHEPPERD SHELTER TUBE COMPLETE & DRILL | Downs Surgical , Ltd. | 1990-10-22 | Traditional | PDF ↗ |
| K900614 | SHEPPERD SHORT MUSCLE RETRACTOR (GS-501-45-V) | Downs Surgical , Ltd. | 1990-10-22 | Traditional | PDF ↗ |
| K900615 | SHEPPERD NERVE ROOT RETRACTOR W/SUCTION & FIBRE | Downs Surgical , Ltd. | 1990-10-22 | Traditional | PDF ↗ |
| K900609 | SHEPPERD STRAIGHT AND CURVED NEEDLES | Downs Surgical , Ltd. | 1990-10-22 | Traditional | PDF ↗ |
| K900608 | SHEPPERD LUMBAR DISCECTOMY SYSTEM | Downs Surgical , Ltd. | 1990-10-22 | Traditional | PDF ↗ |
| K900616 | SHEPPERD CUTTING FORCEPS | Downs Surgical , Ltd. | 1990-10-22 | Traditional | PDF ↗ |
| K900612 | SHEPPERD TREPHINE SET (GS-501-30-V) | Downs Surgical , Ltd. | 1990-10-22 | Traditional | PDF ↗ |
| K900610 | SHEPPERD CANNULA STILLETTE & OBDURATOR SET | Downs Surgical , Ltd. | 1990-10-22 | Traditional | PDF ↗ |
| K900611 | SHEPPERD DILATATION TUBE SET (GS-501-20-H) | Downs Surgical , Ltd. | 1990-10-22 | Traditional | PDF ↗ |
| K903312 | CYGNASCOPE | Cygnus Instruments, Inc. | 1990-10-19 | Traditional | PDF ↗ |
| K903620 | MODIFIED ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM | Smith & Nephew Dyonics, Inc. | 1990-10-12 | Traditional | PDF ↗ |
| K901765 | POSTEROMEDIAL GUIDE | Smith & Nephew Dyonics, Inc. | 1990-06-25 | Traditional | PDF ↗ |
| K901735 | ARTHROSCOPIC SURGERY BLADES DY-3440, 3443, 3444 | Micro-Aire Surgical Instruments, Inc. | 1990-06-20 | Traditional | PDF ↗ |
| K902168 | ARTHROSCOPIC SURGERY BLADES (SEVERAL MODELS) | Micro-Aire Surgical Instruments, Inc. | 1990-06-20 | Traditional | PDF ↗ |
| K901617 | ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM (ECTR) | Smith & Nephew, Inc. | 1990-05-29 | Traditional | PDF ↗ |
| K900812 | MEDICAM ARTHROSCOPE SYSTEMS | Kirschner Medical Corp. | 1990-05-03 | Traditional | PDF ↗ |
| K901505 | ARTHROSCOPIC ELECTROSURGICAL PROBE | Smith & Nephew Dyonics, Inc. | 1990-04-18 | Traditional | PDF ↗ |
| K900680 | EFFNER ARTHROPERISCOPE/ARTHROSCOPE W/REMOV. OPTICS | Effner, Inc. | 1990-03-29 | Traditional | PDF ↗ |
| K900070 | MODIFIED USES OF THE ARTHROSCOPIC SURGICAL SYSTEM | Dyonics, Inc. | 1990-02-16 | Traditional | PDF ↗ |
| K896678 | SILICONE PLUG | Orthopedic Systems, Inc. | 1990-01-30 | Traditional | PDF ↗ |
| K896416 | DYONICS SHOULDER PORTAL SYSTEM | Dyonics, Inc. | 1990-01-02 | Traditional | PDF ↗ |
| K896770 | ARTHRODISTRACTOR | Arthroplastics, Inc. | 1990-01-02 | Traditional | PDF ↗ |
| K896584 | ARTHROSCOPIC TUBING SHEATH | Origin Medsystems, Inc. | 1989-12-27 | Traditional | PDF ↗ |
| K893136 | SURGI-PAK FOR ARTHROSCOPIC ACROMIOPLASTY | Dyonics, Inc. | 1989-12-14 | Traditional | PDF ↗ |
| K896538 | DISPOSABLE 45 DEGREE SHAVER | Bowen & Company, Inc. | 1989-12-06 | Traditional | PDF ↗ |
| K896196 | ARTHROSCOPY DISP. & REUSABLE SHAVER BLADES, RECHAR | Orthoconcept, Inc. | 1989-12-01 | Traditional | PDF ↗ |
| K894990 | DAVOL ARTHROSCOPY CANNULA | Davol, Inc. | 1989-11-08 | Traditional | PDF ↗ |
| K890665 | MODIFIED CANNULA, TROCAR AND OBTURATOR ACCESSORIES | Dyonics, Inc. | 1989-11-03 | Traditional | PDF ↗ |
| K895685 | SMALL JOINT HAND INSTRUMENTS | Leonard Medical, Inc. | 1989-10-16 | Traditional | PDF ↗ |
| K894728 | DYONICS DISPOSABLE ARTHROSCOPIC SURGICAL KNIFE | Dyonics, Inc. | 1989-08-18 | Traditional | PDF ↗ |
| K894558 | MINI LIGHTSCOPE SET, LIGHTSCOPE JR. SET | Optik | 1989-08-07 | Traditional | PDF ↗ |
| K892376 | INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.) | Concept, Inc. | 1989-08-01 | Traditional | PDF ↗ |
| K894303 | MEDSCOPE 4MM ARTHROSCOPE | Medscope Corp. | 1989-07-25 | Traditional | PDF ↗ |
| K892062 | PS3500 ARTHROSCOPIC SURGICAL SYSTEM | Dyonics, Inc. | 1989-06-23 | Traditional | PDF ↗ |
| K884301 | EDWARDS DISPOSABLE ARTHROSCOPY CANNULA | Baxter Healthcare Corp | 1989-03-13 | Traditional | PDF ↗ |
| K884314 | LEONARD MEDICAL 1.7MM ARTHROSCOPE | Leonard Medical, Inc. | 1989-03-13 | Traditional | PDF ↗ |
| K885183 | ENDOSCOPIC LIGHT SOURCE | Technology For Imaging, Inc. | 1989-03-09 | Traditional | PDF ↗ |
| K875130 | BONE NAIL W/WASHER & AN ARTHROSCOPIC INSERTION SYS | Orthopedic Systems, Inc. | 1989-01-30 | Traditional | PDF ↗ |
| K882469 | CORDEX SHAVER, BLADES, RECHARGER AND BATTERIES | Orthoconcept, Inc. | 1988-12-01 | Traditional | PDF ↗ |
| K884302 | EDWARDS ARTHROSCOPIC LEG HOLDER | Baxter Healthcare Corp | 1988-11-30 | Traditional | PDF ↗ |
| K883300 | IRRIGATION SET | Edwards Orthopaedics Div., Baxter Healthcare Corp. | 1988-11-01 | Traditional | PDF ↗ |
| K883361 | ARTHRO-TRAC(TM) | Rudolph Beaver, Inc. | 1988-10-13 | Traditional | PDF ↗ |
| K881715 | 28200 SERIES MICRO-ARTHRO. STERILE DISP. BLADES | KARL STORZ Endoscopy-America, Inc. | 1988-08-30 | Traditional | PDF ↗ |
Product code HRX · Class II · Orthopedic. Data: openFDA.