FDA Inspection
Spinal Elements, IncSpinal Elements, Inc – FDA Inspection, Sep 29, 2017
Record Details
This FDA Inspection record concerns Spinal Elements, Inc, with an inspection on September 29, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Shaquenta Y. Perkins (Issuing Officer)
View Company Profile
ID · 8dd64250-5fcb-470a-b02f-9e61df3f90c0
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1028593
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Spinal Elements, Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| September 8, 2025 | Not classified | Los Angeles District Office | |
| May 14, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 15, 2014 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 30, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Spinal Elements, Inc
- FDA Inspection 1281830 - 2025-09-08
- FDA Inspection 1095313 - 2019-05-14
- FDA Inspection 863246 - 2014-01-15
- FDA Inspection 846624 - 2013-08-30
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.