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FDA 510(k)

KMEDIC EXTERNAL FIXATION DEVICES

K-Number: K030336 · 2003-03-06

ApplicantTeleflex Medical Group
Decision Date2003-03-06
Product CodeJDW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KMEDIC EXTERNAL FIXATION DEVICES is the device name listed in this FDA 510(k) record. The listed applicant is Teleflex Medical Group. It received FDA 510(k) clearance on 2003-03-06 under 510(k) number K030336. The device is classified under product code JDW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KMEDIC EXTERNAL FIXATION DEVICES?

KMEDIC EXTERNAL FIXATION DEVICES is a medical device that received FDA 510(k) clearance on 2003-03-06. The listed applicant is Teleflex Medical Group. The 510(k) number is K030336.

When did KMEDIC EXTERNAL FIXATION DEVICES receive FDA 510(k) clearance?

KMEDIC EXTERNAL FIXATION DEVICES received FDA 510(k) clearance on 2003-03-06, under 510(k) number K030336.

Who is the listed applicant for KMEDIC EXTERNAL FIXATION DEVICES?

The FDA 510(k) record lists Teleflex Medical Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KMEDIC EXTERNAL FIXATION DEVICES?

The FDA product code for KMEDIC EXTERNAL FIXATION DEVICES is JDW.

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Related Devices (Code: JDW)

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

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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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