FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Aptis Medical Distal Radio Ulnar Joint Implant
K Number: K190599
·
Decision May 3, 2019
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
15
Applicant Total
5
Review Days
56
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Basic Information
- Device Name
- Aptis Medical Distal Radio Ulnar Joint Implant
- K Number
- K190599
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3810
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aptis Medical, LLC
- Date Received
- March 8, 2019
- Decision Date
- May 3, 2019
- Product Code
- KXE
- 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 |
|---|---|---|---|
| KXE | Prosthesis, Wrist, Hemi-, Ulnar | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KXE), ordered by most recent decision date.
Aptis Medical Distal Radio Ulnar Joint Implant
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ISOELASTICU
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DISTAL RADIO-ULNAR JOINT IMPLANT
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FDA Class 2
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SBI ULNAR HEAD IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
DISTAL RADIO-ULNAR JOINT IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Aptis Medical, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K142569 | Aptis Medical Distal Radio Ulnar Joint Implant | Apr 3, 2015 | Substantially Equivalent |
| K082839 | DISTAL RADIO-ULNAR JOINT IMPLANT | Oct 24, 2008 | Substantially Equivalent |
| K053119 | DISTAL RADIO-ULNAR JOINT IMPLANT | Dec 7, 2005 | Substantially Equivalent |
| K040497 | DISTAL RADIO-ULNAR JOINT IMPLANT | Jan 26, 2005 | Substantially Equivalent |