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FDA 510(k)

PYLON INTRAMEDULLAARY NAIL SYSTEM

K-Number: K992350 · 1999-09-22

ApplicantAlphatec Mfg., Inc.
Decision Date1999-09-22
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PYLON INTRAMEDULLAARY NAIL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Alphatec Mfg., Inc.. It received FDA 510(k) clearance on 1999-09-22 under 510(k) number K992350. 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 PYLON INTRAMEDULLAARY NAIL SYSTEM?

PYLON INTRAMEDULLAARY NAIL SYSTEM is a medical device that received FDA 510(k) clearance on 1999-09-22. The listed applicant is Alphatec Mfg., Inc.. The 510(k) number is K992350.

When did PYLON INTRAMEDULLAARY NAIL SYSTEM receive FDA 510(k) clearance?

PYLON INTRAMEDULLAARY NAIL SYSTEM received FDA 510(k) clearance on 1999-09-22, under 510(k) number K992350.

Who is the listed applicant for PYLON INTRAMEDULLAARY NAIL SYSTEM?

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

What is the FDA product code for PYLON INTRAMEDULLAARY NAIL SYSTEM?

The FDA product code for PYLON INTRAMEDULLAARY NAIL 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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