Company
United StatesPublic company, NASDAQ: SIBNSI-BONE, Inc. (NASDAQ: SIBN), Santa Clara, CA – FDA Inspections
Inspection records and compliance data for SI-BONE, Inc. in Santa Clara, California. 3 FDA inspections on record, last inspected March 31, 2022. Publicly traded as NASDAQ: SIBN.
Company Profile
This profile covers SI-BONE, Inc. based in Santa Clara, California, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected May 20, 2014. Last inspected March 31, 2022.
Most cited issue areas
- Design validation - user needs and intended uses1 inspection
- Lack of or inadequate DHR procedures1 inspection
- Lack of Written MDR Procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 31, 2022 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1167317 |
| December 6, 2016 | Not classified | Medical Devices & Rad Health | 998766 |
| May 20, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 880126 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
SI-BONE, Inc.
Stock ticker
SIBN
Exchange
NASDAQ
Share price
$24.26
Market cap
$1.1B
Price as of
November 6, 2026
FEI Number
3007700286
Address
471 El Camino Real Ste 101, Santa Clara, California 95050, United States
Country
United States
ID: 53b682b3-f479-43d5-8edf-701ca53ef372