FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HC Biologics Osteopoint Spinal Fixation System
K Number: K250092
·
Decision Mar 27, 2025
Classifications
1
FEI Numbers
413
Registration Numbers
413
Same Product Code
873
Applicant Total
1
Review Days
72
Basic Information
- Device Name
- HC Biologics Osteopoint Spinal Fixation System
- K Number
- K250092
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- HC Biologics LLC
- Date Received
- January 14, 2025
- Decision Date
- March 27, 2025
- Product Code
- NKB
- 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 |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | FDA class 2 | Orthopedic |
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