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FDA 510(k)

POLYAX LOCKED PLATING SYSTEM

K-Number: K060969 · 2006-05-12

ApplicantDePuy Orthopaedics, Inc.
Decision Date2006-05-12
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

POLYAX LOCKED PLATING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is DePuy Orthopaedics, Inc.. It received FDA 510(k) clearance on 2006-05-12 under 510(k) number K060969. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLYAX LOCKED PLATING SYSTEM?

POLYAX LOCKED PLATING SYSTEM is a medical device that received FDA 510(k) clearance on 2006-05-12. The listed applicant is DePuy Orthopaedics, Inc.. The 510(k) number is K060969.

When did POLYAX LOCKED PLATING SYSTEM receive FDA 510(k) clearance?

POLYAX LOCKED PLATING SYSTEM received FDA 510(k) clearance on 2006-05-12, under 510(k) number K060969.

Who is the listed applicant for POLYAX LOCKED PLATING SYSTEM?

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

What is the FDA product code for POLYAX LOCKED PLATING SYSTEM?

The FDA product code for POLYAX LOCKED PLATING SYSTEM is HRS.

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Related Devices (Code: HRS)

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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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