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FDA 510(k)

DEPUY SYNTHES SPINE DENS ACCESS SYSTEM

K-Number: K132910 · 2013-12-16

ApplicantSynthes USA Products, LLC
Decision Date2013-12-16
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DEPUY SYNTHES SPINE DENS ACCESS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Synthes USA Products, LLC. It received FDA 510(k) clearance on 2013-12-16 under 510(k) number K132910. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEPUY SYNTHES SPINE DENS ACCESS SYSTEM?

DEPUY SYNTHES SPINE DENS ACCESS SYSTEM is a medical device that received FDA 510(k) clearance on 2013-12-16. The listed applicant is Synthes USA Products, LLC. The 510(k) number is K132910.

When did DEPUY SYNTHES SPINE DENS ACCESS SYSTEM receive FDA 510(k) clearance?

DEPUY SYNTHES SPINE DENS ACCESS SYSTEM received FDA 510(k) clearance on 2013-12-16, under 510(k) number K132910.

Who is the listed applicant for DEPUY SYNTHES SPINE DENS ACCESS SYSTEM?

The FDA 510(k) record lists Synthes USA Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEPUY SYNTHES SPINE DENS ACCESS SYSTEM?

The FDA product code for DEPUY SYNTHES SPINE DENS ACCESS SYSTEM is HWC. This falls under the Cardiovascular category.

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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.

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