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FDA 510(k)

SYNTHES 2.4 MM TITANIUM (TI.) LOCKING SCREWS

K-Number: K033975 · 2004-03-01

ApplicantSynthes (Usa)
Decision Date2004-03-01
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNTHES 2.4 MM TITANIUM (TI.) LOCKING 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 2004-03-01 under 510(k) number K033975. 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 TITANIUM (TI.) LOCKING SCREWS?

SYNTHES 2.4 MM TITANIUM (TI.) LOCKING SCREWS is a medical device that received FDA 510(k) clearance on 2004-03-01. The listed applicant is Synthes (Usa). The 510(k) number is K033975.

When did SYNTHES 2.4 MM TITANIUM (TI.) LOCKING SCREWS receive FDA 510(k) clearance?

SYNTHES 2.4 MM TITANIUM (TI.) LOCKING SCREWS received FDA 510(k) clearance on 2004-03-01, under 510(k) number K033975.

Who is the listed applicant for SYNTHES 2.4 MM TITANIUM (TI.) LOCKING 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 2.4 MM TITANIUM (TI.) LOCKING SCREWS?

The FDA product code for SYNTHES 2.4 MM TITANIUM (TI.) LOCKING SCREWS is HWC. This falls under the Cardiovascular category.

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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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