FDA 510(k)

Ultima HA Coated Half Pins and Wire

K-Number: K163487 · 2017-02-13

Decision Date2017-02-13

Product CodeJDW

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Ultima HA Coated Half Pins and Wire is a medical device manufactured by Vilex IN Tennessee, Inc.. It received FDA 510(k) clearance on 2017-02-13 under approval number K163487. 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 Ultima HA Coated Half Pins and Wire?

Ultima HA Coated Half Pins and Wire is a medical device that received FDA 510(k) clearance on 2017-02-13. It is manufactured by Vilex IN Tennessee, Inc.. The 510(k) number is K163487.

When was Ultima HA Coated Half Pins and Wire approved by the FDA?

Ultima HA Coated Half Pins and Wire received FDA 510(k) clearance on 2017-02-13, under approval number K163487.

What company makes Ultima HA Coated Half Pins and Wire?

Ultima HA Coated Half Pins and Wire is manufactured by Vilex IN Tennessee, Inc..

What is the FDA product code for Ultima HA Coated Half Pins and Wire?

The FDA product code for Ultima HA Coated Half Pins and Wire is JDW.

Other Devices by Vilex IN Tennessee, Inc.

K151881X-Fix Line Additions K191289Bone Screw Line Addition K190543Cannulated Hemi Implant

Related Devices (Code: JDW)

K182171SMV Scientific K-Wire and PinsSummit Medventures K192768Temporary Fixation PinsEisertech, LLC K200933Syntec Non-Sterile Steinmann Pins SystemSyntec Scientific Corporation K191803Orthopedic Fixation PinTinavi (Anhui) Medical Technologies Co., Ltd. K211508Steinmann Pins and Kirschner WiresStryker GmbH K210784Extended HA Half PinsSmith & Nephew, Inc.

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.