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FDA 510(k)

TITANIUM SPINAL ROD SYSTEM

K-Number: K970635 · 1997-08-14

ApplicantSmith & Nephew, Inc., Orthopaedic Div.
Decision Date1997-08-14
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TITANIUM SPINAL ROD SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc., Orthopaedic Div.. It received FDA 510(k) clearance on 1997-08-14 under 510(k) number K970635. 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 TITANIUM SPINAL ROD SYSTEM?

TITANIUM SPINAL ROD SYSTEM is a medical device that received FDA 510(k) clearance on 1997-08-14. The listed applicant is Smith & Nephew, Inc., Orthopaedic Div.. The 510(k) number is K970635.

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

TITANIUM SPINAL ROD SYSTEM received FDA 510(k) clearance on 1997-08-14, under 510(k) number K970635.

Who is the listed applicant for TITANIUM SPINAL ROD SYSTEM?

The FDA 510(k) record lists Smith & Nephew, Inc., Orthopaedic Div. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TITANIUM SPINAL ROD SYSTEM?

The FDA product code for TITANIUM SPINAL ROD SYSTEM is KWQ.

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Other records listing Smith & Nephew, Inc., Orthopaedic Div. as applicant

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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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