FDA 510(k)

LATERAL COLUMN LENGTH PLATE, MODEL 824073000-3, LOCKED FUSION PLATE, MODEL 824077010, COMPRESSION FUSION PLATE,

K-Number: K091294 · 2009-07-24

Decision Date2009-07-24

Product CodeHRS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

LATERAL COLUMN LENGTH PLATE, MODEL 824073000-3, LOCKED FUSION PLATE, MODEL 824077010, COMPRESSION FUSION PLATE, 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 2009-07-24 under 510(k) number K091294. 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 LATERAL COLUMN LENGTH PLATE, MODEL 824073000-3, LOCKED FUSION PLATE, MODEL 824077010, COMPRESSION FUSION PLATE,?

LATERAL COLUMN LENGTH PLATE, MODEL 824073000-3, LOCKED FUSION PLATE, MODEL 824077010, COMPRESSION FUSION PLATE, is a medical device that received FDA 510(k) clearance on 2009-07-24. The listed applicant is DePuy Orthopaedics, Inc.. The 510(k) number is K091294.

When did LATERAL COLUMN LENGTH PLATE, MODEL 824073000-3, LOCKED FUSION PLATE, MODEL 824077010, COMPRESSION FUSION PLATE, receive FDA 510(k) clearance?

LATERAL COLUMN LENGTH PLATE, MODEL 824073000-3, LOCKED FUSION PLATE, MODEL 824077010, COMPRESSION FUSION PLATE, received FDA 510(k) clearance on 2009-07-24, under 510(k) number K091294.

Who is the listed applicant for LATERAL COLUMN LENGTH PLATE, MODEL 824073000-3, LOCKED FUSION PLATE, MODEL 824077010, COMPRESSION FUSION PLATE,?

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 LATERAL COLUMN LENGTH PLATE, MODEL 824073000-3, LOCKED FUSION PLATE, MODEL 824077010, COMPRESSION FUSION PLATE,?

The FDA product code for LATERAL COLUMN LENGTH PLATE, MODEL 824073000-3, LOCKED FUSION PLATE, MODEL 824077010, COMPRESSION FUSION PLATE, is HRS.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.