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FDA 510(k)

SYNTHES 2.4 MM CANNULATED COMPRESSION SCREW

K-Number: K021556 · 2002-08-09

ApplicantSynthes (Usa)
Decision Date2002-08-09
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNTHES 2.4 MM CANNULATED COMPRESSION SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa). It received FDA 510(k) clearance on 2002-08-09 under 510(k) number K021556. 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 SYNTHES 2.4 MM CANNULATED COMPRESSION SCREW?

SYNTHES 2.4 MM CANNULATED COMPRESSION SCREW is a medical device that received FDA 510(k) clearance on 2002-08-09. The listed applicant is Synthes (Usa). The 510(k) number is K021556.

When did SYNTHES 2.4 MM CANNULATED COMPRESSION SCREW receive FDA 510(k) clearance?

SYNTHES 2.4 MM CANNULATED COMPRESSION SCREW received FDA 510(k) clearance on 2002-08-09, under 510(k) number K021556.

Who is the listed applicant for SYNTHES 2.4 MM CANNULATED COMPRESSION SCREW?

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

What is the FDA product code for SYNTHES 2.4 MM CANNULATED COMPRESSION SCREW?

The FDA product code for SYNTHES 2.4 MM CANNULATED COMPRESSION SCREW is HWC. This falls under the Cardiovascular category.

Related Clinical Trials

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.

Other records listing Synthes (Usa) 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.

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Related Devices (Code: HWC)

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.

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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