FDA Product Code
FDA Product Code HWE — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4820
510(k) Clearances — 76 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K143191 | IntelliSense Drill | Mcginley Innovations | 2015-02-20 | Traditional | PDF ↗ |
| K102743 | ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES | Ortho Solutions Limited | 2011-01-20 | Traditional | PDF ↗ |
| K063688 | SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE | The Anspach Effort, Inc. | 2007-01-16 | Special | PDF ↗ |
| K050766 | EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM | Zimmer Trabecular | 2005-05-26 | Traditional | PDF ↗ |
| K043310 | SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM | Synthes (Usa) | 2005-01-05 | Traditional | PDF ↗ |
| K022744 | REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS | Medical Device Services | 2002-09-18 | Traditional | PDF ↗ |
| K012694 | REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS | Adven Medical | 2002-02-04 | Traditional | PDF ↗ |
| K012676 | REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS | Adven Medical | 2002-02-04 | Traditional | PDF ↗ |
| K990816 | AVCORE SYSTEM | Modular Cutting Systems, Inc. | 1999-09-24 | Traditional | PDF ↗ |
| K973736 | AESCULAP HILAN MOTOR SYSTEM | Aesculap, Inc. | 1997-12-29 | Traditional | PDF ↗ |
| K973560 | BONE GRAFT HARVESTER | Ds Mfg., Inc. | 1997-11-12 | Traditional | PDF ↗ |
| K972508 | SURGICAL BURS AND SURGICAL DRILL BITS | Synvasive Technology, Inc. | 1997-08-26 | Traditional | PDF ↗ |
| K971342 | DISK WHISK CUTTING DEVICE (CONICAL, ELLIPTICAL AND BALL HEAD) | Disk Whisk, Inc. | 1997-07-08 | Traditional | PDF ↗ |
| K971544 | SYNTHES (USA) COMPACT AIR DRIVE II (CAD II) | Synthes (Usa) | 1997-05-28 | Traditional | PDF ↗ |
| K962087 | SERVOTRONIC EC100 SYSTEM | Medicon, Inc. | 1997-04-23 | Traditional | PDF ↗ |
| K970088 | RIWO DRIVE WITH FOOTSWITCH/MOTOR HANDLE, COOMPLETE,6000RPM/3000RPM/ROTARY BLADES AND ABRADERS SEE SECTION 1: | Richard Wolf Medical Instruments Corp. | 1997-04-07 | Traditional | PDF ↗ |
| K970023 | MEDNEXT SURGICAL BUR | Mednext, Inc. | 1997-02-28 | Traditional | PDF ↗ |
| K970040 | SPINE-TECH BONE HARVESTER | Spine-Tech, Inc. | 1997-02-28 | Traditional | PDF ↗ |
| K962913 | SYNTHES STERILE DRILL BITS | Synthes (Usa) | 1996-11-14 | Traditional | PDF ↗ |
| K962800 | STRYKER UNIVERSAL DRILL ATTACHMENTS & ACCESSORIES | Stryker Instruments | 1996-09-11 | Traditional | PDF ↗ |
| K962215 | CONSENSUS POSTERIOR STABILIZED KNEE-INTERCONDYLAR NOTCH ROUTER | U.S. Medical Products, Inc. | 1996-08-15 | Traditional | PDF ↗ |
| K962022 | POWERCUT GOLD SURGICAL SYSTEM | Baxter Healthcare Corp | 1996-08-05 | Traditional | PDF ↗ |
| K961970 | COMMAND 2 MICOELECTRIC SURGICAL SYSTEM | Stryker Corp. | 1996-07-26 | Traditional | PDF ↗ |
| K961759 | CEMENT AND BONE REMOVAL KIT | Maillefer Instruments S.A. | 1996-06-13 | Traditional | PDF ↗ |
| K960720 | EXACTECH STERILE MODULAR DRILL BIT | Exactech, Inc. | 1996-04-23 | Traditional | PDF ↗ |
| K960852 | HALL MODULAR ACETABULAR REAMER SYSTEM | Linvatec Corp. | 1996-03-20 | Traditional | PDF ↗ |
| K953968 | AESCULAP POWER SYSTEMS (ELAN-E & MICROTRON) | Aesculap, Inc. | 1996-02-05 | Traditional | PDF ↗ |
| K955098 | 3M MINI-DRIVER ELECTRIC SYSTEM | 3M Company | 1996-01-22 | Traditional | PDF ↗ |
| K955591 | MICROAIRE SMARTDRIVE SYSTEM | Microaire Surgical Instruments, Inc. | 1996-01-18 | Traditional | PDF ↗ |
| K952543 | GRAFTOLOGER PGH & ACL RECONSTRUCTION INSTRUMENT SET | Neoligaments, Ltd. | 1995-06-22 | Traditional | PDF ↗ |
| K950013 | CONSENSUS(TM) ORTHOPEDIC DRILL BIT | U.S. Medical Products, Inc. | 1995-05-05 | Traditional | PDF ↗ |
| K946197 | CONSENSUS(TM) PATELLA REAMER | U.S. Medical Products, Inc. | 1995-04-05 | Traditional | PDF ↗ |
| K944946 | CONSENUS HIP SYSTEM FEMORAL CANAL STARTER REAMER | U.S. Medical Products, Inc. | 1995-02-01 | Traditional | PDF ↗ |
| K945186 | CONSENUS HIP SYSTEM -- ACETABULAR REAMER | U.S. Medical Products, Inc. | 1995-01-27 | Traditional | PDF ↗ |
| K945189 | CONSENSUS HIP SYSTEM -- CALCAR PLANER | U.S. Medical Products, Inc. | 1995-01-27 | Traditional | PDF ↗ |
| K945208 | CONSENSUS HIP SYSTEM -- TROCHANTERIC CUTTER | U.S. Medical Products, Inc. | 1995-01-27 | Traditional | PDF ↗ |
| K943589 | STRYKER TOTAL PERFORMANCE SYSTEM | Stryker Corp. | 1994-12-15 | Traditional | PDF ↗ |
| K942108 | COHORT BONE BRUSH | Advanced Med/Surg, Inc. | 1994-10-11 | Traditional | PDF ↗ |
| K942956 | SURGICAL INSTRUMENTS AND ACCESSORIES | Stryker Corp. | 1994-09-23 | Traditional | PDF ↗ |
| K942660 | HALL MICROCHOICE ELECTRIC POWERED SYSTEM | Hall Surgical, Division of Zimmer, Inc. | 1994-09-07 | Traditional | PDF ↗ |
| K932918 | TOTAL KNEE KIT | Biodynamic Technologies, Inc. | 1994-09-01 | Traditional | PDF ↗ |
| K931429 | COOL CUT | Mitab | 1994-04-29 | Traditional | PDF ↗ |
| K935753 | THE GRAFTOLOGER | Neoligaments, Ltd. | 1994-04-25 | Traditional | PDF ↗ |
| K931734 | INTERMEDICS ORTHOPEDICS DRILL BITS | Intermedics Orthopedics | 1994-02-22 | Traditional | PDF ↗ |
| K935322 | SNAP BONE REAMER | Surgiquip, Inc. | 1994-01-28 | Traditional | PDF ↗ |
| K935516 | SNAP DRILL | Surgiquip, Inc. | 1994-01-27 | Traditional | PDF ↗ |
| K931176 | BONE SAW BLADES | Betzler Mfg., Inc. | 1994-01-26 | Traditional | PDF ↗ |
| K932699 | ARTHREX AR-8200 SHAVER SYSTEM | Arthrex, Inc. | 1994-01-25 | Traditional | PDF ↗ |
| K935567 | SODEM POWER SYSTEM | Sodemsystems | 1994-01-21 | Traditional | PDF ↗ |
| K931837 | ACUFEX STERILE DRILLS | Acufex Microsurgical, Inc. | 1994-01-07 | Traditional | PDF ↗ |
| K930319 | OSTEON ADAPTOR/CRADLE | United American Medical Co., Inc. | 1994-01-07 | Traditional | PDF ↗ |
| K930363 | POWERED SURGICAL INSTRUMENT ACCESSORY | Intenn Engineering, Inc. | 1994-01-07 | Traditional | PDF ↗ |
| K932261 | ES-100 ACCESSORIES | Elekta Instruments, Inc. | 1994-01-07 | Traditional | PDF ↗ |
| K922056 | HHI ELECTRIC CONSOLE #875-000 | H&H Instruments | 1992-09-18 | Traditional | PDF ↗ |
| K921131 | CKS OSCILLATING SAW BLADE | Techmedica, Inc. | 1992-06-08 | Traditional | PDF ↗ |
| K911929 | SMALL BONE FIXATION SYSTEM | United American Medical Co., Inc. | 1991-07-02 | Traditional | PDF ↗ |
| K911930 | STERILE PACKAGED POWER INSTRUMENT ACCESSORIES | United American Medical Co., Inc. | 1991-07-02 | Traditional | PDF ↗ |
| K902525 | ACE/WILLIAMS MICROSURGERY SAW SYSTEM | Buckman Co., Inc. | 1990-11-26 | Traditional | PDF ↗ |
| K903650 | OSCILLATING SAW BLADES # SO-305,MO-305 AND ZO-305 | Micro-Aire Surgical Instruments, Inc. | 1990-09-14 | Traditional | PDF ↗ |
| K902447 | CORING NEEDLE (TREPHINE, ORTHOPEDIC) | Biomedtrix, Ltd. | 1990-08-14 | Traditional | PDF ↗ |
| K902332 | HALL MODULAR ACETABULAR REAMER SYSTEM | Zimmer, Inc. | 1990-06-25 | Traditional | PDF ↗ |
| K901165 | MODULAR FLEXIBLE DRILLING SYSTEM | Dalton Technology, Inc. | 1990-06-13 | Traditional | PDF ↗ |
| K895198 | HALL VERSIPOWER SURGICAL INSTRUMENT SYSTEM | Zimmer, Inc. | 1989-09-15 | Traditional | PDF ↗ |
| K882008 | ACE SCREW REMOVAL TREPHINE | Buckman Co., Inc. | 1988-06-10 | Traditional | PDF ↗ |
| K880150 | PACESETTER (TM) 3500 ARTHROSCOPIC SURGICAL SYSTEM | Dyonics, Inc. | 1988-03-04 | Traditional | PDF ↗ |
| K874044 | INTRA-ARTICULAR ARTHROSCOPIC SHAVER | Medline Industries, Inc. | 1987-10-15 | Traditional | PDF ↗ |
| K871717 | MODEL 28200C MICRO-ARTHROPLASTY SYSTEM | KARL STORZ Endoscopy-America, Inc. | 1987-06-05 | Traditional | PDF ↗ |
| K864929 | HALL (R) MICRO E POWERED SURGICAL INSTRUMENT SYST | Hall Surgical, Division of Zimmer, Inc. | 1987-01-28 | Traditional | PDF ↗ |
| K855216 | 3M ARTHROSCOPIC SURGICAL SYSTEM | 3M Company | 1986-03-04 | Traditional | PDF ↗ |
| K854987 | INTRA-ARTICULATED ARTHROSCOPIC POWER SYSTEM | Richard Wolf Medical Instruments Corp. | 1986-02-11 | Traditional | PDF ↗ |
| K853376 | MORGAN SUTURE-DRILL | Bowen & Company, Inc. | 1985-11-13 | Traditional | PDF ↗ |
| K853489 | DEXTRA PRECISION POWER SYSTEM | Chattanooga Group, Inc. | 1985-09-30 | Traditional | PDF ↗ |
| K833940 | TORQUE PLUS CATALOG 30120 | Concept, Inc. | 1983-12-28 | Traditional | PDF ↗ |
| K802105 | C-BLADE | Cutter Laboratories, Inc. | 1980-09-16 | Traditional | PDF ↗ |
| K792353 | INTRA-ARTICULATED EDGER-PLANER SYSTEM | Richard Wolf Medical Instruments Corp. | 1979-12-27 | Traditional | PDF ↗ |
| K760977 | CHARNLEY FEMUR DRILL #1 AND #2 | Codman & Shurtleff, Inc. | 1976-11-16 | Traditional | PDF ↗ |
Product code HWE · Class I · General, Plastic Surgery. Data: openFDA.