FDA Inspection
Stryker SpineStryker Spine – FDA Inspection, Sep 29, 2011
Record Details
This FDA Inspection record concerns Stryker Spine, with an inspection on September 29, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Stryker Spine
- Inspection Date
- September 29, 2011
- Product Type
- Devices
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ID · b785a1bb-07a6-46c4-aa21-7b5604f5b4cf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 750642
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
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Other FDA inspections of Stryker Spine
4| Date | Classification | Office | Project area |
|---|---|---|---|
| December 12, 2024 | Not classified | Office of Inspections and Investigations | |
| November 15, 2018 | Not classified | Office of Inspections and Investigations | |
| February 10, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 28, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Stryker Spine
- FDA Inspection 1257920 - 2024-12-12
- FDA Inspection 1102881 - 2018-11-15
- FDA Inspection 966647 - 2016-02-10
- FDA Inspection 586860 - 2009-05-28
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