FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Integra TITAN Reverse Shoulder System
K Number: K190588
·
Decision Dec 2, 2019
Classifications
1
FEI Numbers
194
Registration Numbers
194
Same Product Code
182
Applicant Total
13
Review Days
270
Basic Information
- Device Name
- Integra TITAN Reverse Shoulder System
- K Number
- K190588
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3660
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Integra LifeSciences Corporation
- Date Received
- March 7, 2019
- Decision Date
- December 2, 2019
- Product Code
- PHX
- 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 |
|---|---|---|---|
| PHX | Shoulder Prosthesis, Reverse Configuration | FDA class 2 | Orthopedic |
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