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FDA 510(k)

PHUSIS ABSORBABLE INTERFERENCE SCREW

K-Number: K970829 · 1998-12-22

ApplicantTornier
Decision Date1998-12-22
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PHUSIS ABSORBABLE INTERFERENCE SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Tornier. It received FDA 510(k) clearance on 1998-12-22 under 510(k) number K970829. 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 PHUSIS ABSORBABLE INTERFERENCE SCREW?

PHUSIS ABSORBABLE INTERFERENCE SCREW is a medical device that received FDA 510(k) clearance on 1998-12-22. The listed applicant is Tornier. The 510(k) number is K970829.

When did PHUSIS ABSORBABLE INTERFERENCE SCREW receive FDA 510(k) clearance?

PHUSIS ABSORBABLE INTERFERENCE SCREW received FDA 510(k) clearance on 1998-12-22, under 510(k) number K970829.

Who is the listed applicant for PHUSIS ABSORBABLE INTERFERENCE SCREW?

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

What is the FDA product code for PHUSIS ABSORBABLE INTERFERENCE SCREW?

The FDA product code for PHUSIS ABSORBABLE 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.

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