Prosthesis, Subtalar, Plug, Polymer
The Subtalar Plug Polymer Prosthesis is a surgically implanted polymer device placed in the sinus tarsi of the subtalar joint to limit excessive hindfoot pronation, used in the treatment of pediatric flatfoot deformity (flexible pes planus) or adult-acquired flatfoot conditions. Classified as a Class 2 implantable device under 21 CFR 888.3040 within the Orthopedic specialty, it requires 510(k) premarket notification. It carries an implant flag due to its surgically placed nature.
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Basic Information
- Product Code
- MJW
- Device Class
- FDA class 2
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- 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 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.