FDA Inspection
Stryker SpineStryker Spine – FDA Inspection, Mar 17, 2010
Record Details
This FDA Inspection record concerns Stryker Spine, with an inspection on March 17, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Stryker Spine
- Inspection Date
- March 17, 2010
- Product Type
- Devices
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ID · a1c80080-8da5-46ef-be1c-e4a8b37187b9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 656354
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.198(e)(3)Device identification and control number
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Stryker Spine
7| Date | Classification | Office | Project area |
|---|---|---|---|
| September 27, 2024 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| September 13, 2021 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 1, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 11, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 18, 2014 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Stryker Spine
- FDA Inspection 1251341 - 2024-09-27
- FDA Inspection 1155286 - 2021-09-13
- FDA Inspection 1099091 - 2019-08-01
- FDA Inspection 965950 - 2016-03-11
- FDA Inspection 883814 - 2014-06-18
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