FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MECTALIF ANTERIOR
K Number: K124034
·
Decision May 17, 2013
Classifications
1
FEI Numbers
253
Registration Numbers
253
Same Product Code
200
Applicant Total
39
Review Days
140
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Basic Information
- Device Name
- MECTALIF ANTERIOR
- K Number
- K124034
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medacta International
- Date Received
- December 28, 2012
- Decision Date
- May 17, 2013
- Product Code
- OVD
- 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 |
|---|---|---|---|
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | FDA class 2 | Orthopedic |
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| 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 |