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FDA 510(k)

UNITRAX C-TAPER NECK ADJUSTMENT SLEEVE

K-Number: K992570 · 1999-09-01

ApplicantHowmedica Osteonics Corp.
Decision Date1999-09-01
Product CodeKWL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

UNITRAX C-TAPER NECK ADJUSTMENT SLEEVE is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp.. It received FDA 510(k) clearance on 1999-09-01 under 510(k) number K992570. The device is classified under product code KWL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNITRAX C-TAPER NECK ADJUSTMENT SLEEVE?

UNITRAX C-TAPER NECK ADJUSTMENT SLEEVE is a medical device that received FDA 510(k) clearance on 1999-09-01. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K992570.

When did UNITRAX C-TAPER NECK ADJUSTMENT SLEEVE receive FDA 510(k) clearance?

UNITRAX C-TAPER NECK ADJUSTMENT SLEEVE received FDA 510(k) clearance on 1999-09-01, under 510(k) number K992570.

Who is the listed applicant for UNITRAX C-TAPER NECK ADJUSTMENT SLEEVE?

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

What is the FDA product code for UNITRAX C-TAPER NECK ADJUSTMENT SLEEVE?

The FDA product code for UNITRAX C-TAPER NECK ADJUSTMENT SLEEVE is KWL.

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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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