FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HYALEX® MTP Hemiarthroplasty Implant
K Number: K250074
·
Decision Apr 3, 2026
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
45
Applicant Total
1
Review Days
448
Basic Information
- Device Name
- HYALEX® MTP Hemiarthroplasty Implant
- K Number
- K250074
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3730
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hyalex Orthopaedics, Inc.
- Date Received
- January 10, 2025
- Decision Date
- April 3, 2026
- 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 |
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