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FDA 510(k)

SYNTHES 3.5MM CORTEX SCREWS

K-Number: K043185 · 2005-02-03

ApplicantSynthes (Usa)
Decision Date2005-02-03
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNTHES 3.5MM CORTEX SCREWS is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa). It received FDA 510(k) clearance on 2005-02-03 under 510(k) number K043185. 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 3.5MM CORTEX SCREWS?

SYNTHES 3.5MM CORTEX SCREWS is a medical device that received FDA 510(k) clearance on 2005-02-03. The listed applicant is Synthes (Usa). The 510(k) number is K043185.

When did SYNTHES 3.5MM CORTEX SCREWS receive FDA 510(k) clearance?

SYNTHES 3.5MM CORTEX SCREWS received FDA 510(k) clearance on 2005-02-03, under 510(k) number K043185.

Who is the listed applicant for SYNTHES 3.5MM CORTEX SCREWS?

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 3.5MM CORTEX SCREWS?

The FDA product code for SYNTHES 3.5MM CORTEX SCREWS is HWC. This falls under the Cardiovascular category.

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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.

K121601SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATEK120854SYNTHES VA LCP ANKLE TRAUMA SYSTEMK120717SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)K120070SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEMK120083SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN)K111667SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS

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Related Devices (Code: HWC)

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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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