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FDA 510(k)

THORACOLUMBAR SPINAL ROD SYSTEM (EMPOWER)

K-Number: K983899 · 1998-12-22

ApplicantUnited States Surgical, A Division of Tyco Healthc
Decision Date1998-12-22
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

THORACOLUMBAR SPINAL ROD SYSTEM (EMPOWER) is the device name listed in this FDA 510(k) record. The listed applicant is United States Surgical, A Division of Tyco Healthc. It received FDA 510(k) clearance on 1998-12-22 under 510(k) number K983899. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THORACOLUMBAR SPINAL ROD SYSTEM (EMPOWER)?

THORACOLUMBAR SPINAL ROD SYSTEM (EMPOWER) is a medical device that received FDA 510(k) clearance on 1998-12-22. The listed applicant is United States Surgical, A Division of Tyco Healthc. The 510(k) number is K983899.

When did THORACOLUMBAR SPINAL ROD SYSTEM (EMPOWER) receive FDA 510(k) clearance?

THORACOLUMBAR SPINAL ROD SYSTEM (EMPOWER) received FDA 510(k) clearance on 1998-12-22, under 510(k) number K983899.

Who is the listed applicant for THORACOLUMBAR SPINAL ROD SYSTEM (EMPOWER)?

The FDA 510(k) record lists United States Surgical, A Division of Tyco Healthc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THORACOLUMBAR SPINAL ROD SYSTEM (EMPOWER)?

The FDA product code for THORACOLUMBAR SPINAL ROD SYSTEM (EMPOWER) is KWQ.

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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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