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FDA 510(k)

TWINFIX FT PK

K-Number: K072785 · 2007-12-10

ApplicantSmith & Nephew Inc., Endoscopy Division
Decision Date2007-12-10
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TWINFIX FT PK is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Inc., Endoscopy Division. It received FDA 510(k) clearance on 2007-12-10 under 510(k) number K072785. 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 TWINFIX FT PK?

TWINFIX FT PK is a medical device that received FDA 510(k) clearance on 2007-12-10. The listed applicant is Smith & Nephew Inc., Endoscopy Division. The 510(k) number is K072785.

When did TWINFIX FT PK receive FDA 510(k) clearance?

TWINFIX FT PK received FDA 510(k) clearance on 2007-12-10, under 510(k) number K072785.

Who is the listed applicant for TWINFIX FT PK?

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

What is the FDA product code for TWINFIX FT PK?

The FDA product code for TWINFIX FT PK is HWC. This falls under the Cardiovascular category.

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Other records listing Smith & Nephew Inc., Endoscopy Division as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K121904GYNECOLOGY STERILIZATION TRAYK102982ENDOBUTTON DIRECTK082215OSTEORAPTOR SUTURE ANCHORK081098ENDOBUTTON CONTINUOUS LOOP (CL)K071586BIORAPTOR 2.3 PK SUTURE ANCHORK070908SMITH & NEPHEW KINSA RC SUTURE ANCHOR

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Related Devices (Code: HWC)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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