FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MYSPINE PEDICLE SCREW PLACEMENT GUIDES
K Number: K132788
·
Decision May 23, 2014
Classifications
1
FEI Numbers
342
Registration Numbers
342
Same Product Code
302
Applicant Total
39
Review Days
259
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Basic Information
- Device Name
- MYSPINE PEDICLE SCREW PLACEMENT GUIDES
- K Number
- K132788
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medacta International
- Date Received
- September 6, 2013
- Decision Date
- May 23, 2014
- Product Code
- MNI
- 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 |
|---|---|---|---|
| MNI | Orthosis, Spinal Pedicle Fixation | FDA class 2 | Orthopedic |
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Other Clearances by Medacta International
| K Number | Device Name | ||
|---|---|---|---|
| K160605 | MectaLIF Anterior Stand-Alone | Jul 21, 2016 | Substantially Equivalent |
| K160289 | MasterLoc Stem | May 20, 2016 | Substantially Equivalent |
| 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 |
| K143453 | Mpact Double Mobility System | Mar 2, 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 |