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FDA 510(k)

SYNTHES 3.0 MM PC-FIX SYSTEM

K-Number: K981372 · 1998-05-11

ApplicantSynthes (Usa)
Decision Date1998-05-11
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNTHES 3.0 MM PC-FIX SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa). It received FDA 510(k) clearance on 1998-05-11 under 510(k) number K981372. 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 3.0 MM PC-FIX SYSTEM?

SYNTHES 3.0 MM PC-FIX SYSTEM is a medical device that received FDA 510(k) clearance on 1998-05-11. The listed applicant is Synthes (Usa). The 510(k) number is K981372.

When did SYNTHES 3.0 MM PC-FIX SYSTEM receive FDA 510(k) clearance?

SYNTHES 3.0 MM PC-FIX SYSTEM received FDA 510(k) clearance on 1998-05-11, under 510(k) number K981372.

Who is the listed applicant for SYNTHES 3.0 MM PC-FIX SYSTEM?

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 3.0 MM PC-FIX SYSTEM?

The FDA product code for SYNTHES 3.0 MM PC-FIX SYSTEM 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)

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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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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