Implant, Temporal
The Temporal Implant is a surgical device used in general and plastic surgery procedures involving the temporal region of the skull. It is classified as FDA Class 2, requiring 510(k) premarket notification to demonstrate substantial equivalence to a predicate device. The product code is MNF and it is regulated under 21 CFR 878.3550. Notably, this device carries an implant flag, meaning it is surgically placed inside the body.
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Basic Information
- Product Code
- MNF
- Device Class
- FDA class 2
- Regulation Number
- 878.3550
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.