FDA 510(k)

BIOABSORBABLE INTERFERENCE SCREWS

K-Number: K984320 · 1999-01-28

Decision Date1999-01-28

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

BIOABSORBABLE INTERFERENCE SCREWS 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 1999-01-28 under 510(k) number K984320. 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 BIOABSORBABLE INTERFERENCE SCREWS?

BIOABSORBABLE INTERFERENCE SCREWS is a medical device that received FDA 510(k) clearance on 1999-01-28. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K984320.

When did BIOABSORBABLE INTERFERENCE SCREWS receive FDA 510(k) clearance?

BIOABSORBABLE INTERFERENCE SCREWS received FDA 510(k) clearance on 1999-01-28, under 510(k) number K984320.

Who is the listed applicant for BIOABSORBABLE INTERFERENCE SCREWS?

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 BIOABSORBABLE INTERFERENCE SCREWS?

The FDA product code for BIOABSORBABLE INTERFERENCE SCREWS 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.