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FDA 510(k)

ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR)

K-Number: K010322 · 2001-05-02

ApplicantOrthodyne, Inc.
Decision Date2001-05-02
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR) is the device name listed in this FDA 510(k) record. The listed applicant is Orthodyne, Inc.. It received FDA 510(k) clearance on 2001-05-02 under 510(k) number K010322. 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 ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR)?

ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR) is a medical device that received FDA 510(k) clearance on 2001-05-02. The listed applicant is Orthodyne, Inc.. The 510(k) number is K010322.

When did ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR) receive FDA 510(k) clearance?

ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR) received FDA 510(k) clearance on 2001-05-02, under 510(k) number K010322.

Who is the listed applicant for ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR)?

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

What is the FDA product code for ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR)?

The FDA product code for ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR) is HSB.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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