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FDA 510(k)

OsteoMed PINNACLE Driver

K-Number: K162542 · 2017-05-19

ApplicantOsteomed
Decision Date2017-05-19
Product CodeHBE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

OsteoMed PINNACLE Driver is a medical device manufactured by Osteomed. It received FDA 510(k) clearance on 2017-05-19 under approval number K162542. The device is classified under product code HBE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OsteoMed PINNACLE Driver?

OsteoMed PINNACLE Driver is a medical device that received FDA 510(k) clearance on 2017-05-19. It is manufactured by Osteomed. The 510(k) number is K162542.

When was OsteoMed PINNACLE Driver approved by the FDA?

OsteoMed PINNACLE Driver received FDA 510(k) clearance on 2017-05-19, under approval number K162542.

What company makes OsteoMed PINNACLE Driver?

OsteoMed PINNACLE Driver is manufactured by Osteomed.

What is the FDA product code for OsteoMed PINNACLE Driver?

The FDA product code for OsteoMed PINNACLE Driver is HBE.

Other Devices by Osteomed

K161041OsteoMed ExtremiLOCK Wrist Plating System K162544OsteoMed PINNACLE Driver K203479ExtremiLOCK Lateral Ankle Fusion Plates

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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