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FDA 510(k)

PLLA, HA SCREW

K-Number: K080358 · 2008-04-23

ApplicantSmith & Nephew Inc., Endoscopy Div.
Decision Date2008-04-23
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PLLA, HA SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Inc., Endoscopy Div.. It received FDA 510(k) clearance on 2008-04-23 under 510(k) number K080358. 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 PLLA, HA SCREW?

PLLA, HA SCREW is a medical device that received FDA 510(k) clearance on 2008-04-23. The listed applicant is Smith & Nephew Inc., Endoscopy Div.. The 510(k) number is K080358.

When did PLLA, HA SCREW receive FDA 510(k) clearance?

PLLA, HA SCREW received FDA 510(k) clearance on 2008-04-23, under 510(k) number K080358.

Who is the listed applicant for PLLA, HA SCREW?

The FDA 510(k) record lists Smith & Nephew Inc., Endoscopy Div. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PLLA, HA SCREW?

The FDA product code for PLLA, HA SCREW 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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