FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HILINE Fixation System
K Number: K230565
·
Decision Apr 20, 2023
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
36
Applicant Total
172
Review Days
50
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Basic Information
- Device Name
- HILINE Fixation System
- K Number
- K230565
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3010
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Globus Medical, Inc.
- Date Received
- March 1, 2023
- Decision Date
- April 20, 2023
- Product Code
- OWI
- 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 |
|---|---|---|---|
| OWI | Bone Fixation Cerclage, Sublaminar | FDA class 2 | Orthopedic |
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