FDA 510(k)

OsteoMed PINNACLE Driver

K-Number: K162542 · 2017-05-19

Decision Date2017-05-19

Product CodeHBE

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

OsteoMed PINNACLE Driver is the device name listed in this FDA 510(k) record. The listed applicant is Osteomed. It received FDA 510(k) clearance on 2017-05-19 under 510(k) 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. The listed applicant is Osteomed. The 510(k) number is K162542.

When did OsteoMed PINNACLE Driver receive FDA 510(k) clearance?

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

Who is the listed applicant for OsteoMed PINNACLE Driver?

The FDA 510(k) record lists Osteomed as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OsteoMed PINNACLE Driver?

The FDA product code for OsteoMed PINNACLE Driver is HBE.

Other records listing Osteomed as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.