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FDA 510(k)

Temporary Fixation Pins

K-Number: K192768 · 2019-12-26

ApplicantEisertech, LLC
Decision Date2019-12-26
Product CodeJDW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Temporary Fixation Pins is the device name listed in this FDA 510(k) record. The listed applicant is Eisertech, LLC. It received FDA 510(k) clearance on 2019-12-26 under 510(k) number K192768. 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 Temporary Fixation Pins?

Temporary Fixation Pins is a medical device that received FDA 510(k) clearance on 2019-12-26. The listed applicant is Eisertech, LLC. The 510(k) number is K192768.

When did Temporary Fixation Pins receive FDA 510(k) clearance?

Temporary Fixation Pins received FDA 510(k) clearance on 2019-12-26, under 510(k) number K192768.

Who is the listed applicant for Temporary Fixation Pins?

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

What is the FDA product code for Temporary Fixation Pins?

The FDA product code for Temporary Fixation Pins is JDW.

Other records listing Eisertech, LLC as applicant

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.

K190565Cervical Plate

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.

K260073XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mmBiodynamik, Inc.K250316Meduloc Intramedullary Fracture Fixation (IFF) SystemMeduloc, LLCK241357XT3 SystemBiodynamik, Inc.K223112MAVERICK Mini External Fixation SystemSmith & Nephew, Inc.K213874MAVERICK External Fixation SystemSmith & Nephew, Inc.K211508Steinmann Pins and Kirschner WiresStryker GmbH

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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