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FDA 510(k)

EXACTECH STERILE MODULAR DRILL BIT

K-Number: K960720 · 1996-04-23

ApplicantExactech, Inc.
Decision Date1996-04-23
Product CodeHWE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EXACTECH STERILE MODULAR DRILL BIT is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 1996-04-23 under 510(k) number K960720. The device is classified under product code HWE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXACTECH STERILE MODULAR DRILL BIT?

EXACTECH STERILE MODULAR DRILL BIT is a medical device that received FDA 510(k) clearance on 1996-04-23. The listed applicant is Exactech, Inc.. The 510(k) number is K960720.

When did EXACTECH STERILE MODULAR DRILL BIT receive FDA 510(k) clearance?

EXACTECH STERILE MODULAR DRILL BIT received FDA 510(k) clearance on 1996-04-23, under 510(k) number K960720.

Who is the listed applicant for EXACTECH STERILE MODULAR DRILL BIT?

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

What is the FDA product code for EXACTECH STERILE MODULAR DRILL BIT?

The FDA product code for EXACTECH STERILE MODULAR DRILL BIT is HWE.

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Related Devices (Code: HWE)

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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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