FDA 510(k)

SMITH & NEPHEW SUTURE HAPLA INTERFERENCE SCREW

K-Number: K002274 · 2001-03-07

Decision Date2001-03-07

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

SMITH & NEPHEW SUTURE HAPLA INTERFERENCE SCREW 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 2001-03-07 under 510(k) number K002274. 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 SMITH & NEPHEW SUTURE HAPLA INTERFERENCE SCREW?

SMITH & NEPHEW SUTURE HAPLA INTERFERENCE SCREW is a medical device that received FDA 510(k) clearance on 2001-03-07. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K002274.

When did SMITH & NEPHEW SUTURE HAPLA INTERFERENCE SCREW receive FDA 510(k) clearance?

SMITH & NEPHEW SUTURE HAPLA INTERFERENCE SCREW received FDA 510(k) clearance on 2001-03-07, under 510(k) number K002274.

Who is the listed applicant for SMITH & NEPHEW SUTURE HAPLA INTERFERENCE SCREW?

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 SMITH & NEPHEW SUTURE HAPLA INTERFERENCE SCREW?

The FDA product code for SMITH & NEPHEW SUTURE HAPLA INTERFERENCE 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.