FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® Instruments
K Number: K183119
·
Decision Feb 6, 2019
Classifications
1
FEI Numbers
155
Registration Numbers
155
Same Product Code
130
Applicant Total
172
Review Days
89
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Basic Information
- Device Name
- SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® Instruments
- K Number
- K183119
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Globus Medical, Inc.
- Date Received
- November 9, 2018
- Decision Date
- February 6, 2019
- Product Code
- OUR
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OUR | Sacroiliac Joint Fixation | FDA class 2 | Orthopedic |
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