FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇺 Australia
Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20° Hooded Acetabular Liner
K Number: K153131
·
Decision Jun 3, 2016
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
157
Applicant Total
3
Review Days
217
Basic Information
- Device Name
- Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20° Hooded Acetabular Liner
- K Number
- K153131
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3353
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SIGNATURE ORTHOPAEDICS PTY LTD.
- Date Received
- October 30, 2015
- Decision Date
- June 3, 2016
- Product Code
- MEH
- 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 |
|---|---|---|---|
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | FDA class 2 | Orthopedic |
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