FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BioPoly Lesser Toe Hemiarthroplasty Implant
K Number: K222964
·
Decision Nov 22, 2022
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
45
Applicant Total
3
Review Days
56
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- BioPoly Lesser Toe Hemiarthroplasty Implant
- K Number
- K222964
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3730
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BioPoly, LLC
- Date Received
- September 27, 2022
- Decision Date
- November 22, 2022
- Product Code
- KWD
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KWD), ordered by most recent decision date.
HYALEX® MTP Hemiarthroplasty Implant
FDA 510(k)
FDA Class 2
·Orthopedic
Accu-Joint Hemi Implant
FDA 510(k)
FDA Class 2
·Orthopedic
Montross Extremity Medical Hemi Implant System
FDA 510(k)
FDA Class 2
·Orthopedic
restor3d MTP Implant
FDA 510(k)
FDA Class 2
·Orthopedic
BioPoly Great Toe Hemiarthroplasty Implant
FDA 510(k)
FDA Class 2
·Orthopedic
Accu-Joint Hemi Implant
FDA 510(k)
FDA Class 2
·Orthopedic