FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Cartiva SCI Disposable Instrumentation Set
K Number: K181348
·
Decision Jun 20, 2018
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
1
Applicant Total
3
Review Days
30
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Basic Information
- Device Name
- Cartiva SCI Disposable Instrumentation Set
- K Number
- K181348
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.4505
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cartiva, Inc.
- Date Received
- May 21, 2018
- Decision Date
- June 20, 2018
- Product Code
- QBO
- 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 |
|---|---|---|---|
| QBO | Instruments Designed For Press-Fit Osteochondral Implants | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
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