OsteoMed PINNACLE Driver
FDA 510(k) K162544 · Osteomed
510(k) numberK162544
Submission
- Device name
- OsteoMed PINNACLE Driver
- Applicant
- Osteomed
Addison, TX, US - Received
- September 12, 2016
- Decision date
- April 4, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K211584 | Oral Surgery ContraKMW · Traditional | Nakanishi, Inc. | 08/19/2021SE |
| K171155 | Surgical Angle Handpiece, Surgical Straight HandpieceKMW · Traditional | Nakanishi, Inc. | 11/21/2017SE |
| K080939 | Surgical Handpieces, Mikro Saw HandpiecesKMW · Traditional | W&H Dentalwerk Buermoos GmbH | 07/29/2008SE |
| K994298 | Frios MicrosawKMW · Traditional | Friadent GmbH | 02/18/2000SE |
| K971692 | Osteopower System and AccessoriesKMW · Traditional | Osteomed Corp. | 06/27/1997SE |
| K970953 | E-Type Speed Reducer Contra AngleKMW · Traditional | Nsk Nakanishi, Inc. | 04/15/1997SE |
| K932255 | Young D'GranulatorKMW · Traditional | Young Dental Manufacturing Co. 1, LLC | 04/15/1994SE |
| K862110 | Osseodent Drilling SystemKMW · Traditional | Otc/America | 08/07/1986SE |
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| 510(k) | Device | Decision |
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| K212570 | OsteoPlan SystemDZJ · Traditional | 02/11/2022SE |
| K203479 | ExtremiLOCK Lateral Ankle Fusion PlatesHRS · Traditional | 02/24/2021SE |
| K202105 | OsteoMed ExtremiFix Mini & Small System TrayKCT · Traditional | 10/29/2020SE |
| K202680 | OsteoMed ExtremiFix Mini & Small Cannulated Screw SystemHWC · Special | 10/15/2020SE |
| K173391 | OsteoMed QuickFix Hybrid MMF Sterilization TrayKCT · Traditional | 05/10/2018SE |
| K162542 | OsteoMed PINNACLE DriverHBE · Traditional | 05/19/2017SE |
| K163303 | OsteoMed ExtremiFix Mid and Large Screw SystemHWC · Traditional | 04/04/2017SE |
| K161041 | OsteoMed ExtremiLOCK Wrist Plating SystemHRS · Special | 05/19/2016SE |
| K152145 | OsteoMed ExtremiLOCK Wrist Plating SystemHRS · Traditional | 12/21/2015SE |
| K151195 | OsteoMed IMF ScrewDZL · Traditional | 09/21/2015SE |
Questions and answers
When was OsteoMed PINNACLE Driver cleared by the FDA?
OsteoMed PINNACLE Driver (K162544) received a 510(k) decision of Substantially Equivalent on April 4, 2017, 204 days after the submission was received.
What is the product code of K162544?
The FDA product code is KMW – Handpiece, Rotary Bone Cutting, a Class II (moderate risk) device regulated under 21 CFR 872.4120.