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FDA 510(k)

G/K SFN AND STN LOCKING NAILS

K-Number: K983358 · 1998-11-18

ApplicantHowmedica, Inc.
Decision Date1998-11-18
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

G/K SFN AND STN LOCKING NAILS is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica, Inc.. It received FDA 510(k) clearance on 1998-11-18 under 510(k) number K983358. 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 G/K SFN AND STN LOCKING NAILS?

G/K SFN AND STN LOCKING NAILS is a medical device that received FDA 510(k) clearance on 1998-11-18. The listed applicant is Howmedica, Inc.. The 510(k) number is K983358.

When did G/K SFN AND STN LOCKING NAILS receive FDA 510(k) clearance?

G/K SFN AND STN LOCKING NAILS received FDA 510(k) clearance on 1998-11-18, under 510(k) number K983358.

Who is the listed applicant for G/K SFN AND STN LOCKING NAILS?

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

What is the FDA product code for G/K SFN AND STN LOCKING NAILS?

The FDA product code for G/K SFN AND STN LOCKING NAILS is HSB.

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Other records listing Howmedica, Inc. as applicant

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Related Devices (Code: HSB)

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

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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