FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEDRON Cervical Spacers (HEDRON C-MIS Spacer)
K Number: K253876
·
Decision Dec 22, 2025
Classifications
1
FEI Numbers
230
Registration Numbers
230
Same Product Code
161
Applicant Total
172
Review Days
18
Basic Information
- Device Name
- HEDRON Cervical Spacers (HEDRON C-MIS Spacer)
- K Number
- K253876
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Globus Medical, Inc.
- Date Received
- December 4, 2025
- Decision Date
- December 22, 2025
- Product Code
- OVE
- 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 |
|---|---|---|---|
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | FDA class 2 | Orthopedic |
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