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FDA 510(k)

SYNTHES (USA) [SYNTHES[ SELF-DRILLING SCHANZ SCREW

K-Number: K952296 · 1995-08-18

ApplicantSynthes (Usa)
Decision Date1995-08-18
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNTHES (USA) [SYNTHES[ SELF-DRILLING SCHANZ 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 1995-08-18 under 510(k) number K952296. 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 (USA) [SYNTHES[ SELF-DRILLING SCHANZ SCREW?

SYNTHES (USA) [SYNTHES[ SELF-DRILLING SCHANZ SCREW is a medical device that received FDA 510(k) clearance on 1995-08-18. The listed applicant is Synthes (Usa). The 510(k) number is K952296.

When did SYNTHES (USA) [SYNTHES[ SELF-DRILLING SCHANZ SCREW receive FDA 510(k) clearance?

SYNTHES (USA) [SYNTHES[ SELF-DRILLING SCHANZ SCREW received FDA 510(k) clearance on 1995-08-18, under 510(k) number K952296.

Who is the listed applicant for SYNTHES (USA) [SYNTHES[ SELF-DRILLING SCHANZ 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 (USA) [SYNTHES[ SELF-DRILLING SCHANZ SCREW?

The FDA product code for SYNTHES (USA) [SYNTHES[ SELF-DRILLING SCHANZ SCREW is HWC. This falls under the Cardiovascular category.

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Other records listing Synthes (Usa) as applicant

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Related Devices (Code: HWC)

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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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