FDA Inspection 1308134 - Unik Orthopedics, Inc - March 13, 2026

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Record Details

This FDA Inspection record concerns Unik Orthopedics, Inc, with an inspection on March 13, 2026, issued by the Center for Devices and Radiological Health, covering devices.

Company: Unik Orthopedics, Inc
Inspection Date: March 13, 2026
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · ae57f68e-c4fd-4b03-bb2b-0ce3726ba0ab

Violation Codes7

ISO 13485:2016 Clause 5.6.1ISO 13485:2016 Clause 7.1ISO 13485:2016 Clause 7.4.1ISO 13485:2016 Clause 7.5.8ISO 13485:2016 Clause 8.2.2ISO 13485:2016 Clause 8.2.4ISO 13485:2016 Clause 8.5.2

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