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FDA 510(k)

SYNTHES STERILE 3.5 MM AND 4.0 MM CANNULATED SCREWS

K-Number: K963192 · 1996-11-08

ApplicantSynthes (Usa)
Decision Date1996-11-08
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

SYNTHES STERILE 3.5 MM AND 4.0 MM CANNULATED 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 1996-11-08 under 510(k) number K963192. 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 for Some Indications.

Frequently Asked Questions

What is the SYNTHES STERILE 3.5 MM AND 4.0 MM CANNULATED SCREWS?

SYNTHES STERILE 3.5 MM AND 4.0 MM CANNULATED SCREWS is a medical device that received FDA 510(k) clearance on 1996-11-08. The listed applicant is Synthes (Usa). The 510(k) number is K963192.

When did SYNTHES STERILE 3.5 MM AND 4.0 MM CANNULATED SCREWS receive FDA 510(k) clearance?

SYNTHES STERILE 3.5 MM AND 4.0 MM CANNULATED SCREWS received FDA 510(k) clearance on 1996-11-08, under 510(k) number K963192.

Who is the listed applicant for SYNTHES STERILE 3.5 MM AND 4.0 MM CANNULATED 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 STERILE 3.5 MM AND 4.0 MM CANNULATED SCREWS?

The FDA product code for SYNTHES STERILE 3.5 MM AND 4.0 MM CANNULATED 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.

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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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