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FDA 510(k)

SYNTHES (USA) STERNAL FIXATION SYSTEM - LINE EXTENSION

K-Number: K081700 · 2008-07-17

ApplicantSynthes (Usa)
Decision Date2008-07-17
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNTHES (USA) STERNAL FIXATION SYSTEM - LINE EXTENSION is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa). It received FDA 510(k) clearance on 2008-07-17 under 510(k) number K081700. 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) STERNAL FIXATION SYSTEM - LINE EXTENSION?

SYNTHES (USA) STERNAL FIXATION SYSTEM - LINE EXTENSION is a medical device that received FDA 510(k) clearance on 2008-07-17. The listed applicant is Synthes (Usa). The 510(k) number is K081700.

When did SYNTHES (USA) STERNAL FIXATION SYSTEM - LINE EXTENSION receive FDA 510(k) clearance?

SYNTHES (USA) STERNAL FIXATION SYSTEM - LINE EXTENSION received FDA 510(k) clearance on 2008-07-17, under 510(k) number K081700.

Who is the listed applicant for SYNTHES (USA) STERNAL FIXATION SYSTEM - LINE EXTENSION?

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) STERNAL FIXATION SYSTEM - LINE EXTENSION?

The FDA product code for SYNTHES (USA) STERNAL FIXATION SYSTEM - LINE EXTENSION is HWC. This falls under the Cardiovascular category.

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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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