FDA 510(k)

PIP Fix

K-Number: K181192 · 2018-10-22

Decision Date2018-10-22

Product CodeJEC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

PIP Fix is the device name listed in this FDA 510(k) record. The listed applicant is Hand Biomechanics Lab, Inc.. It received FDA 510(k) clearance on 2018-10-22 under 510(k) number K181192. The device is classified under product code JEC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PIP Fix?

PIP Fix is a medical device that received FDA 510(k) clearance on 2018-10-22. The listed applicant is Hand Biomechanics Lab, Inc.. The 510(k) number is K181192.

When did PIP Fix receive FDA 510(k) clearance?

PIP Fix received FDA 510(k) clearance on 2018-10-22, under 510(k) number K181192.

Who is the listed applicant for PIP Fix?

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

What is the FDA product code for PIP Fix?

The FDA product code for PIP Fix is JEC.

Other records listing Hand Biomechanics Lab, Inc. 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.

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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.