FDA Inspection
Spine Wave, Inc.Spine Wave, Inc. – FDA Inspection, Jan 10, 2017
Record Details
This FDA Inspection record concerns Spine Wave, Inc., with an inspection on January 10, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b53caa8b-e706-4a96-86c8-c7cf92eb0949
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 997070
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Spine Wave, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| April 21, 2026 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 25, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 24, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 3, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Spine Wave, Inc.
- FDA Inspection 1314334 - 2026-04-21
- FDA Inspection 1203863 - 2023-04-25
- FDA Inspection 833623 - 2013-05-24
- FDA Inspection 611259 - 2009-09-03
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