150 Driver/Reamer
FDA 510(k) K800312 · Black & Decker(Tm)
510(k) numberK800312
Submission
- Device name
- 150 Driver/Reamer
- Applicant
- Black & Decker(Tm)
Mchenry, IL, US - Received
- February 12, 1980
- Decision date
- February 22, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KIJ – Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code KIJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K163308 | SmartoKIJ · Special | Jeil Medical Corporation | 12/27/2016SE |
| K112599 | Insurgical Single Use Power EquipmentKIJ · Traditional | Insurgical, LLC | 11/06/2012SE |
| K101563 | SmartoKIJ · Traditional | Jeil Medical Corporation | 12/17/2010SE |
| K972367 | Stryker System 4000 Heavy Duty Battery Powered EquipmentKIJ · Traditional | Stryker Instruments | 09/04/1997SE |
| K970378 | Stryker 2115 Replacement Battery (2115)KIJ · Traditional | Implant Resource, Inc. | 04/30/1997SE |
| K960711 | Acumed Bone Graft SystemKIJ · Traditional | Acu Med, Inc. | 05/07/1996SE |
| K951450 | System 2000 Replacement Battery, System 2000-EXTENDED Run Replacement BatteryKIJ · Traditional | Strenumed, Inc. | 05/17/1995SE |
| K944488 | S & S Orthopedic Wire Driver 701KIJ · Traditional | S & S Orthopedic , Ltd. | 03/02/1995SE |
| K941285 | Arthrex Graft Harvesting KitKIJ · Traditional | Arthrex, Inc. | 11/14/1994SE |
| K933101 | The Osteomed B Power System and AccessoriesKIJ · Traditional | Osteomed Corp. | 11/07/1994SE |
More from Osteomed Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K820351 | Cast Cutter/Cast Saw/InstrumentLGH · Traditional | 03/02/1982SE |
| K812440 | Power Pack · Traditional | 11/02/1981SE |
| K812439 | Dual MPC Charger · Traditional | 11/02/1981SE |
| K812438 | Sagittal SawGEY · Traditional | 11/02/1981SE |
| K812437 | 150 Driver ReamerGEY · Traditional | 11/02/1981SE |
| K812436 | 450/800 DrillHBC · Traditional | 11/02/1981SE |
| K800315 | Dual MPC ChargerKIJ · Traditional | 03/19/1980SE |
| K800314 | Power PackKIJ · Traditional | 03/19/1980SE |
| K800313 | Sagittal SawKIJ · Traditional | 02/22/1980SE |
| K800311 | 450 DRILL/800 DrillKIJ · Traditional | 02/22/1980SE |
Questions and answers
When was 150 Driver/Reamer cleared by the FDA?
150 Driver/Reamer (K800312) received a 510(k) decision of Substantially Equivalent on February 22, 1980, 10 days after the submission was received.
What is the product code of K800312?
The FDA product code is KIJ – Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment, a Class I (low risk) device regulated under 21 CFR 878.4820.