Arthrosurface, Inc. – FDA Inspection, Nov 9, 2012

Record Details

This FDA Inspection record concerns Arthrosurface, Inc., with an inspection on November 9, 2012, issued by the Center for Devices and Radiological Health, covering devices.

Company: Arthrosurface, Inc.
Inspection Date: November 9, 2012
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · d3449498-49b6-4551-9f0a-865215a523f7

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 806730
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 806.10(a)(1)Report of risk to health
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
21 CFR 820.80(d)Lack of or inadequate final acceptance procedures

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Other FDA inspections of Arthrosurface, Inc.

Date	Classification	Office	Project area
April 1, 2026	NAI	New England District Office	Postmarket Assurance: Medical Devices
August 6, 2025	Not classified	New England District Office
November 2, 2018	Not classified	New England District Office
December 8, 2015	VAI	Center for Devices and Radiological Health	Bioresearch Monitoring
October 5, 2015	NAI	Center for Biologics Evaluation and Research	Human Cellular, Tissue, and Gene Therapies