FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM & BALTEUM-ONE Lumbar Plate System
K Number: K222572
·
Decision Oct 18, 2022
Classifications
1
FEI Numbers
356
Registration Numbers
356
Same Product Code
665
Applicant Total
4
Review Days
54
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Basic Information
- Device Name
- FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM & BALTEUM-ONE Lumbar Plate System
- K Number
- K222572
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dio Medical Corporation
- Date Received
- August 25, 2022
- Decision Date
- October 18, 2022
- Product Code
- KWQ
- 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 |
|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | FDA class 2 | Orthopedic |
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