FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RESTORIS POROUS PARTIAL KNEE SYSTEM
K Number: K133811
·
Decision Jul 8, 2014
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
4
Applicant Total
33
Review Days
204
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Basic Information
- Device Name
- RESTORIS POROUS PARTIAL KNEE SYSTEM
- K Number
- K133811
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3535
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mako Surgical Corp.
- Date Received
- December 16, 2013
- Decision Date
- July 8, 2014
- Product Code
- NJD
- 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 |
|---|---|---|---|
| NJD | Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer | FDA class 2 | Orthopedic |
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| K220459 | Mako Total Knee Application | Apr 15, 2022 | Substantially Equivalent |
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| K193128 | Mako Total Hip Application | Feb 2, 2020 | Substantially Equivalent |
| K191998 | Mako Total Hip Application, Mako Total Knee Application | Sep 24, 2019 | Substantially Equivalent |