FDA 510(k)

PERI-LOC LOCKING HOLE INSERTS AND CABLE ACCESSORIES

K-Number: K100325 · 2010-05-04

Decision Date2010-05-04

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

PERI-LOC LOCKING HOLE INSERTS AND CABLE ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2010-05-04 under 510(k) number K100325. 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 PERI-LOC LOCKING HOLE INSERTS AND CABLE ACCESSORIES?

PERI-LOC LOCKING HOLE INSERTS AND CABLE ACCESSORIES is a medical device that received FDA 510(k) clearance on 2010-05-04. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K100325.

When did PERI-LOC LOCKING HOLE INSERTS AND CABLE ACCESSORIES receive FDA 510(k) clearance?

PERI-LOC LOCKING HOLE INSERTS AND CABLE ACCESSORIES received FDA 510(k) clearance on 2010-05-04, under 510(k) number K100325.

Who is the listed applicant for PERI-LOC LOCKING HOLE INSERTS AND CABLE ACCESSORIES?

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

What is the FDA product code for PERI-LOC LOCKING HOLE INSERTS AND CABLE ACCESSORIES?

The FDA product code for PERI-LOC LOCKING HOLE INSERTS AND CABLE ACCESSORIES 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.