FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MCI - CMF System
K Number: K182758
·
Decision Dec 5, 2019
Classifications
1
FEI Numbers
106
Registration Numbers
106
Same Product Code
291
Applicant Total
2
Review Days
433
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Basic Information
- Device Name
- MCI - CMF System
- K Number
- K182758
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4760
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mci Medical Concept Innovation, Inc.
- Date Received
- September 28, 2018
- Decision Date
- December 5, 2019
- Product Code
- JEY
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| JEY | Plate, Bone | FDA class 2 | Dental |
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Other Clearances by Mci Medical Concept Innovation, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K212391 | MCI-Neuro Fixation System | Oct 21, 2022 | Substantially Equivalent |