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FDA 510(k)

OCTANE-C INTERBODY FUSION DEVICE SYSTEM

K-Number: K103655 · 2011-06-30

ApplicantExactech, Inc.
Decision Date2011-06-30
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OCTANE-C INTERBODY FUSION DEVICE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2011-06-30 under 510(k) number K103655. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OCTANE-C INTERBODY FUSION DEVICE SYSTEM?

OCTANE-C INTERBODY FUSION DEVICE SYSTEM is a medical device that received FDA 510(k) clearance on 2011-06-30. The listed applicant is Exactech, Inc.. The 510(k) number is K103655.

When did OCTANE-C INTERBODY FUSION DEVICE SYSTEM receive FDA 510(k) clearance?

OCTANE-C INTERBODY FUSION DEVICE SYSTEM received FDA 510(k) clearance on 2011-06-30, under 510(k) number K103655.

Who is the listed applicant for OCTANE-C INTERBODY FUSION DEVICE SYSTEM?

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 OCTANE-C INTERBODY FUSION DEVICE SYSTEM?

The FDA product code for OCTANE-C INTERBODY FUSION DEVICE SYSTEM is ODP.

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Related Devices (Code: ODP)

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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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