FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)
K Number: K201944
·
Decision Sep 10, 2020
Classifications
1
FEI Numbers
106
Registration Numbers
106
Same Product Code
291
Applicant Total
45
Review Days
59
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Basic Information
- Device Name
- DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)
- K Number
- K201944
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.4760
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Synthes (USA) Products, LLC
- Date Received
- July 13, 2020
- Decision Date
- September 10, 2020
- 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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