FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MOBIS II
K Number: K131372
·
Decision Jul 2, 2013
Classifications
1
FEI Numbers
418
Registration Numbers
418
Same Product Code
890
Applicant Total
23
Review Days
50
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Basic Information
- Device Name
- MOBIS II
- K Number
- K131372
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Signus Medizintechnik GmbH
- Date Received
- May 13, 2013
- Decision Date
- July 2, 2013
- Product Code
- MAX
- 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 |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | FDA class 2 | Orthopedic |
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| K151704 | Diplomat® Spinal System | Apr 13, 2016 | Substantially Equivalent |
| K141405 | MOBIS II ST SPINAL IMPLANT | Sep 16, 2014 | Substantially Equivalent |
| K123758 | TASMIN R | Jan 14, 2014 | Substantially Equivalent |
| K122317 | TETRIS II | Aug 29, 2012 | Substantially Equivalent |
| K111792 | MOBIS, MOVAL, SEMIAL, TETRISMODEL PEEK AND TITANIUM, KIMBA MODEL STANDARD AND MINI | Mar 5, 2012 | Substantially Equivalent |
| K090387 | KAINOS+ | Sep 28, 2009 | Substantially Equivalent |