FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
Mpact Double Mobility System
K Number: K143453
·
Decision Mar 2, 2015
Classifications
1
FEI Numbers
266
Registration Numbers
266
Same Product Code
560
Applicant Total
39
Review Days
89
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Basic Information
- Device Name
- Mpact Double Mobility System
- K Number
- K143453
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3358
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medacta International
- Date Received
- December 3, 2014
- Decision Date
- March 2, 2015
- Product Code
- LPH
- 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 |
|---|---|---|---|
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | FDA class 2 | Orthopedic |
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|---|---|---|---|
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| K153664 | M.U.S.T. Pedicle Screw System | Jan 19, 2016 | Substantially Equivalent |
| K151531 | MasterLoc Stem | Oct 30, 2015 | Substantially Equivalent |
| K142744 | Mecta-C TiPEEK | May 7, 2015 | Substantially Equivalent |
| K142069 | GMK EXTENSION | Dec 2, 2014 | Substantially Equivalent |
| K141988 | M.U.S.T PEDICLE SCREW SYSTEM | Aug 19, 2014 | Substantially Equivalent |
| K141044 | M.U.S.T. EXTENSION | Aug 18, 2014 | Substantially Equivalent |
| K140826 | GMK SPHERE EXTENSION | Jul 15, 2014 | Substantially Equivalent |
| K140361 | META-C CERVICAL PLATE | Jun 12, 2014 | Substantially Equivalent |