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FDA 510(k)

SULZER ORTHOPEDICS SYSORB INTERFERENCE SCREWS

K-Number: K983592 · 1999-01-28

ApplicantSulzer Orthopedics, Inc.
Decision Date1999-01-28
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SULZER ORTHOPEDICS SYSORB INTERFERENCE SCREWS is the device name listed in this FDA 510(k) record. The listed applicant is Sulzer Orthopedics, Inc.. It received FDA 510(k) clearance on 1999-01-28 under 510(k) number K983592. 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 SULZER ORTHOPEDICS SYSORB INTERFERENCE SCREWS?

SULZER ORTHOPEDICS SYSORB INTERFERENCE SCREWS is a medical device that received FDA 510(k) clearance on 1999-01-28. The listed applicant is Sulzer Orthopedics, Inc.. The 510(k) number is K983592.

When did SULZER ORTHOPEDICS SYSORB INTERFERENCE SCREWS receive FDA 510(k) clearance?

SULZER ORTHOPEDICS SYSORB INTERFERENCE SCREWS received FDA 510(k) clearance on 1999-01-28, under 510(k) number K983592.

Who is the listed applicant for SULZER ORTHOPEDICS SYSORB INTERFERENCE SCREWS?

The FDA 510(k) record lists Sulzer Orthopedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SULZER ORTHOPEDICS SYSORB INTERFERENCE SCREWS?

The FDA product code for SULZER ORTHOPEDICS SYSORB INTERFERENCE SCREWS 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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