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FDA 510(k)

RETROGRADE ROD SYSTEM

K-Number: K982602 · 1998-09-14

ApplicantHowmedica Corp.
Decision Date1998-09-14
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RETROGRADE ROD SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1998-09-14 under 510(k) number K982602. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RETROGRADE ROD SYSTEM?

RETROGRADE ROD SYSTEM is a medical device that received FDA 510(k) clearance on 1998-09-14. The listed applicant is Howmedica Corp.. The 510(k) number is K982602.

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

RETROGRADE ROD SYSTEM received FDA 510(k) clearance on 1998-09-14, under 510(k) number K982602.

Who is the listed applicant for RETROGRADE ROD SYSTEM?

The FDA 510(k) record lists Howmedica Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RETROGRADE ROD SYSTEM?

The FDA product code for RETROGRADE ROD SYSTEM is HSB.

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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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