FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HemiCAP MTP Resurfacing Hemi-Arthroplasty System
K Number: K152454
·
Decision Apr 11, 2016
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
45
Applicant Total
26
Review Days
227
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Basic Information
- Device Name
- HemiCAP MTP Resurfacing Hemi-Arthroplasty System
- K Number
- K152454
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3730
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Arthrosurface, Inc.
- Date Received
- August 28, 2015
- Decision Date
- April 11, 2016
- 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
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Accu-Joint Hemi Implant
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Montross Extremity Medical Hemi Implant System
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BioPoly Lesser Toe Hemiarthroplasty Implant
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
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