FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CAPRI Corpectomy Cage System
K Number: K211320
·
Decision Feb 24, 2022
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
17
Applicant Total
100
Review Days
300
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Basic Information
- Device Name
- CAPRI Corpectomy Cage System
- K Number
- K211320
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- K2m, Inc.
- Date Received
- April 30, 2021
- Decision Date
- February 24, 2022
- Product Code
- PLR
- 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 |
|---|---|---|---|
| PLR | Spinal Vertebral Body Replacement Device - Cervical | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PLR), ordered by most recent decision date.
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FDA 510(k)
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NEXXT MATRIXX System
FDA 510(k)
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