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FDA 510(k)

EXACTECH PROLIANT POLYAXIAL PEDICLE SCREW SYSTEM

K-Number: K102870 · 2011-01-21

ApplicantExactech, Inc.
Decision Date2011-01-21
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EXACTECH PROLIANT POLYAXIAL PEDICLE SCREW 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 2011-01-21 under 510(k) number K102870. The device is classified under product code MNH. It was reviewed by the OR advisory panel. Product code MNH falls under the category of ENT, which includes ear, nose, and throat diagnostic and surgical devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXACTECH PROLIANT POLYAXIAL PEDICLE SCREW SYSTEM?

EXACTECH PROLIANT POLYAXIAL PEDICLE SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2011-01-21. The listed applicant is Exactech, Inc.. The 510(k) number is K102870.

When did EXACTECH PROLIANT POLYAXIAL PEDICLE SCREW SYSTEM receive FDA 510(k) clearance?

EXACTECH PROLIANT POLYAXIAL PEDICLE SCREW SYSTEM received FDA 510(k) clearance on 2011-01-21, under 510(k) number K102870.

Who is the listed applicant for EXACTECH PROLIANT POLYAXIAL PEDICLE SCREW 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 EXACTECH PROLIANT POLYAXIAL PEDICLE SCREW SYSTEM?

The FDA product code for EXACTECH PROLIANT POLYAXIAL PEDICLE SCREW SYSTEM is MNH. This falls under the ENT category.

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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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