Company
United StatesSpine Wave, Inc., Shelton, CT – FDA Inspections
Inspection records and compliance data for Spine Wave, Inc. in Shelton, Connecticut. 5 FDA inspections on record, 1 Form 483, last inspected April 21, 2026.
Company Profile
This profile covers Spine Wave, Inc. based in Shelton, Connecticut, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 0
- NAI
- 5
- Form 483s
- 1
- Warning letters
- 0
First inspected September 3, 2009. Last inspected April 21, 2026.
Most cited issue areas
- Lack of or inadequate complaint procedures1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 21, 2026 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1314334 |
| April 25, 2023 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1203863 |
| January 10, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 997070 |
| May 24, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 833623 |
| September 3, 2009 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 611259 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Spine Wave, Inc.
FEI Number
3004638600
Address
3 Enterprise Dr Ste 210, Shelton, Connecticut 06484, United States
Country
United States
ID: 0db78bd2-56ee-41d2-b916-66111cff70a2