KIJ — Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment Class I
FDA product code KIJ covers "Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment", a Class I medical device regulated under 21 CFR 878.4820. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KIJ
- Device Class
- Class I
- Regulation Number
- 878.4820
- Submission Type
- Review Panel
- OR
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K163308 | jeil medical corporation | SMARTO | December 27, 2016 |
| K112599 | insurgical | INSURGICAL SINGLE USE POWER EQUIPMENT | November 6, 2012 |
| K101563 | jeil medical corporation | SMARTO | December 17, 2010 |
| K972367 | stryker instruments | STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT | September 4, 1997 |
| K970378 | implant resource | STRYKER 2115 REPLACEMENT BATTERY (2115) | April 30, 1997 |
| K960711 | acu med | ACUMED BONE GRAFT SYSTEM | May 7, 1996 |
| K951450 | strenumed | SYSTEM 2000 REPLACEMENT BATTERY, SYSTEM 2000-EXTENDED RUN REPLACEMENT BATTERY | May 17, 1995 |
| K944488 | s and s orthopedic | S & S ORTHOPEDIC WIRE DRIVER 701 | March 2, 1995 |
| K941285 | arthrex | ARTHREX GRAFT HARVESTING KIT | November 14, 1994 |
| K933101 | osteomed | THE OSTEOMED B POWER SYSTEM AND ACCESSORIES | November 7, 1994 |
| K933337 | r and d batteries | R AND D BATTERY REPLACEMENT | April 5, 1994 |
| K931395 | micro surgical instruments | SERIES 5000 BATTERY POWERED INSTRUMENT SYSTEM | January 28, 1994 |
| K932307 | 3m health care | 3M MAXI-DRIVER II DBATTERY POWERED SYSTEM | January 7, 1994 |
| K884839 | dyonics | MODIFIED SAW BLADES TO THE SAGITAL SAW | December 7, 1988 |
| K873766 | bowen and company | STERNAL POWER AWL | November 14, 1988 |
| K864137 | bio-rad | LYPHOCHEK IMMUNOASSAY SERUM CONTROL LEVEL I,II,III | November 7, 1986 |
| K850789 | t. korossurgical instruments | FLUTED SUCTION MENISCAL CUTTER | June 28, 1985 |
| K844162 | aeg power tool | EZ 505 | March 11, 1985 |
| K844163 | aeg power tool | EZ 502 | March 11, 1985 |
| K822790 | xomed | MICRO-CRAFT OSCILLATING SAW HANDPIECE | October 22, 1982 |