FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Matira Anterior Cervical System
K Number: K172086
·
Decision Sep 22, 2017
Classifications
1
FEI Numbers
356
Registration Numbers
356
Same Product Code
665
Applicant Total
9
Review Days
73
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Basic Information
- Device Name
- Matira Anterior Cervical System
- K Number
- K172086
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kalitec Direct, LLC
- Date Received
- July 11, 2017
- Decision Date
- September 22, 2017
- Product Code
- KWQ
- 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 |
|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
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Other Clearances by Kalitec Direct, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K180401 | TiWAVE-C Porous Titanium Cervical Cage | Jun 14, 2018 | Substantially Equivalent |
| K172808 | CosmoLock Pedicle Screw System | Oct 25, 2017 | Substantially Equivalent |
| K170342 | Ocata Anterior Cervical System | May 9, 2017 | Substantially Equivalent |
| K163471 | Kalitec Direct InSePtion MIS Fixation System | Mar 16, 2017 | Substantially Equivalent |
| K140678 | COSMOLOCK PEDICLE SCREW SYSTEM | Jun 19, 2014 | Substantially Equivalent |
| K133815 | INTESS CERVICAL CAGE SYSTEM | Apr 16, 2014 | Substantially Equivalent |
| K123100 | INTESS LUMBAR CAGE | Mar 28, 2013 | Substantially Equivalent |
| K111370 | ODALYS PEDICLE SCREW SYSTEM | Sep 21, 2011 | Substantially Equivalent |