FDA Product Code
FDA Product Code KIJ — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4820
510(k) Clearances — 29 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K163308 | SMARTO | Jeil Medical Corporation | 2016-12-27 | Special | PDF ↗ |
| K112599 | INSURGICAL SINGLE USE POWER EQUIPMENT | Insurgical, LLC | 2012-11-06 | Traditional | PDF ↗ |
| K101563 | SMARTO | Jeil Medical Corporation | 2010-12-17 | Traditional | PDF ↗ |
| K972367 | STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT | Stryker Instruments | 1997-09-04 | Traditional | PDF ↗ |
| K970378 | STRYKER 2115 REPLACEMENT BATTERY (2115) | Implant Resource, Inc. | 1997-04-30 | Traditional | PDF ↗ |
| K960711 | ACUMED BONE GRAFT SYSTEM | Acu Med, Inc. | 1996-05-07 | Traditional | PDF ↗ |
| K951450 | SYSTEM 2000 REPLACEMENT BATTERY, SYSTEM 2000-EXTENDED RUN REPLACEMENT BATTERY | Strenumed, Inc. | 1995-05-17 | Traditional | PDF ↗ |
| K944488 | S & S ORTHOPEDIC WIRE DRIVER 701 | S & S Orthopedic , Ltd. | 1995-03-02 | Traditional | PDF ↗ |
| K941285 | ARTHREX GRAFT HARVESTING KIT | Arthrex, Inc. | 1994-11-14 | Traditional | PDF ↗ |
| K933101 | THE OSTEOMED B POWER SYSTEM AND ACCESSORIES | Osteomed Corp. | 1994-11-07 | Traditional | PDF ↗ |
| K933337 | R AND D BATTERY REPLACEMENT | R & D Batteries, Inc. | 1994-04-05 | Traditional | PDF ↗ |
| K931395 | SERIES 5000 BATTERY POWERED INSTRUMENT SYSTEM | Micro Surgical Instruments Corp. | 1994-01-28 | Traditional | PDF ↗ |
| K932307 | 3M MAXI-DRIVER II DBATTERY POWERED SYSTEM | 3M Health Care, Ltd. | 1994-01-07 | Traditional | PDF ↗ |
| K884839 | MODIFIED SAW BLADES TO THE SAGITAL SAW | Dyonics, Inc. | 1988-12-07 | Traditional | PDF ↗ |
| K873766 | STERNAL POWER AWL | Bowen & Company, Inc. | 1988-11-14 | Traditional | PDF ↗ |
| K864137 | LYPHOCHEK IMMUNOASSAY SERUM CONTROL LEVEL I,II,III | Bio-Rad | 1986-11-07 | Traditional | PDF ↗ |
| K850789 | FLUTED SUCTION MENISCAL CUTTER | T. Korossurgical Instruments Corp. | 1985-06-28 | Traditional | PDF ↗ |
| K844162 | EZ 505 | Aeg Power Tool Corp. | 1985-03-11 | Traditional | PDF ↗ |
| K844163 | EZ 502 | Aeg Power Tool Corp. | 1985-03-11 | Traditional | PDF ↗ |
| K822790 | MICRO-CRAFT OSCILLATING SAW HANDPIECE | Xomed, Inc. | 1982-10-22 | Traditional | PDF ↗ |
| K820367 | INTRA-ARTICULAR SURGICAL SYSTEM | Dyonics, Inc. | 1982-05-07 | Traditional | PDF ↗ |
| K800315 | DUAL MPC CHARGER | Black & Decker(Tm) | 1980-03-19 | Traditional | PDF ↗ |
| K800314 | POWER PACK | Black & Decker(Tm) | 1980-03-19 | Traditional | PDF ↗ |
| K800312 | 150 DRIVER/REAMER | Black & Decker(Tm) | 1980-02-22 | Traditional | PDF ↗ |
| K800313 | SAGITTAL SAW | Black & Decker(Tm) | 1980-02-22 | Traditional | PDF ↗ |
| K800311 | 450 DRILL/800 DRILL | Black & Decker(Tm) | 1980-02-22 | Traditional | PDF ↗ |
| K790063 | DRILL, CORDLESS SURGICAL | Richard'S Medical Equip., Inc. | 1979-02-05 | Traditional | PDF ↗ |
| K780645 | HMD-2000 BATTERY-POWERED MINI-DRILL, THE | Medishield, Inc. | 1978-05-03 | Traditional | PDF ↗ |
| K771218 | INTRA-ARTICULAR SHAVER | Dyonics, Inc. | 1978-02-01 | Traditional | PDF ↗ |
Product code KIJ · Class I · General, Plastic Surgery. Data: openFDA.