DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)
FDA 510(k) clearance K201944 · decided 2020-09-10
Clearance details
- K-number
- K201944
- Device name
- DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)
- Applicant
- Synthes (USA) Products, LLC
- Decision
- Substantially Equivalent
- Date received
- 2020-07-13
- Decision date
- 2020-09-10
- Days to decision
- 59 days
- Clearance type
- Special
- Product code
- JEY
- Device class
- 2
- Regulation number
- 872.4760
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- West Chester, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.