FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CAPRI Corpectomy Cage System
K Number: K170055
·
Decision Apr 13, 2017
Classifications
1
FEI Numbers
222
Registration Numbers
222
Same Product Code
276
Applicant Total
16
Review Days
97
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Basic Information
- Device Name
- CAPRI Corpectomy Cage System
- K Number
- K170055
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- K2m
- Date Received
- January 6, 2017
- Decision Date
- April 13, 2017
- Product Code
- MQP
- 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 |
|---|---|---|---|
| MQP | Spinal Vertebral Body Replacement Device | FDA class 2 | Orthopedic |
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|---|---|---|---|
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| K171704 | CAPRI Corpectomy Cage System | Aug 31, 2017 | Substantially Equivalent |
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