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FDA 510(k)

KAPP SPINAL BUTTON

K-Number: K843368 · 1984-09-12

ApplicantKapp Surgical Instrument, Inc.
Decision Date1984-09-12
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KAPP SPINAL BUTTON is the device name listed in this FDA 510(k) record. The listed applicant is Kapp Surgical Instrument, Inc.. It received FDA 510(k) clearance on 1984-09-12 under 510(k) number K843368. The device is classified under product code HTN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KAPP SPINAL BUTTON?

KAPP SPINAL BUTTON is a medical device that received FDA 510(k) clearance on 1984-09-12. The listed applicant is Kapp Surgical Instrument, Inc.. The 510(k) number is K843368.

When did KAPP SPINAL BUTTON receive FDA 510(k) clearance?

KAPP SPINAL BUTTON received FDA 510(k) clearance on 1984-09-12, under 510(k) number K843368.

Who is the listed applicant for KAPP SPINAL BUTTON?

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

What is the FDA product code for KAPP SPINAL BUTTON?

The FDA product code for KAPP SPINAL BUTTON is HTN.

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Other records listing Kapp Surgical Instrument, Inc. as applicant

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.

K200289Michler-Kapp Cardiovascular Vent CatheterK072216KAPP BARI-RING ENDOSCOPIC MARKER, MODEL K-9536K050384KAPP BARI-RING, MODEL KS-BR-2005K050655MONDEAL RADIUS HO SYSTEM, MODEL KS-MR-2005K050657MONDEAL CONTOUR HO SYSTEMK033930KAPP CUSTOM ULNAR HEAD WRIST IMPLANT

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Related Devices (Code: HTN)

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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