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FDA 510(k)

PERFORATED BIOABSORBABLE INTERFERENCE SCREW MEGAFIX

K-Number: K030848 · 2003-06-02

ApplicantKarl Storz Endoscopy
Decision Date2003-06-02
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PERFORATED BIOABSORBABLE INTERFERENCE SCREW MEGAFIX is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz Endoscopy. It received FDA 510(k) clearance on 2003-06-02 under 510(k) number K030848. 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 PERFORATED BIOABSORBABLE INTERFERENCE SCREW MEGAFIX?

PERFORATED BIOABSORBABLE INTERFERENCE SCREW MEGAFIX is a medical device that received FDA 510(k) clearance on 2003-06-02. The listed applicant is Karl Storz Endoscopy. The 510(k) number is K030848.

When did PERFORATED BIOABSORBABLE INTERFERENCE SCREW MEGAFIX receive FDA 510(k) clearance?

PERFORATED BIOABSORBABLE INTERFERENCE SCREW MEGAFIX received FDA 510(k) clearance on 2003-06-02, under 510(k) number K030848.

Who is the listed applicant for PERFORATED BIOABSORBABLE INTERFERENCE SCREW MEGAFIX?

The FDA 510(k) record lists Karl Storz Endoscopy as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PERFORATED BIOABSORBABLE INTERFERENCE SCREW MEGAFIX?

The FDA product code for PERFORATED BIOABSORBABLE INTERFERENCE SCREW MEGAFIX 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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