FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
APTUS ULNA PLATES
K Number: K103332
·
Decision Jan 24, 2011
Classifications
1
FEI Numbers
505
Registration Numbers
505
Same Product Code
1254
Applicant Total
19
Review Days
73
Basic Information
- Device Name
- APTUS ULNA PLATES
- K Number
- K103332
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MEDARTIS AG
- Date Received
- November 12, 2010
- Decision Date
- January 24, 2011
- Product Code
- HRS
- 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 |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | FDA class 2 | Orthopedic |
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Other Clearances by MEDARTIS AG
| K Number | Device Name | ||
|---|---|---|---|
| K142906 | APTUS Wrist 2.5 System | Jun 9, 2015 | Substantially Equivalent |
| K142581 | APTUS Foot System | Apr 9, 2015 | Substantially Equivalent |
| K141232 | APTUS ULNA SHORTENING 2.5 | Jun 23, 2014 | Substantially Equivalent |
| K133460 | APTUS CANNULATED COMPRESSION SCREWS | Dec 18, 2013 | Substantially Equivalent |
| K120108 | APTUS PROXIMAL HUMERUS SYSTEM | Apr 27, 2012 | Substantially Equivalent |
| K112169 | APTUS WRIST ARTHRODESIS PLATES | Jan 6, 2012 | Substantially Equivalent |
| K112560 | APTUS(R) DISTAL HUMERUS SYSTEM | Dec 15, 2011 | Substantially Equivalent |
| K110908 | APTUS FOOT 3.5 SYSTEM | Jun 28, 2011 | Substantially Equivalent |
| K110658 | APTUS CANNULATED COMPRESSION SCREWS | Jun 2, 2011 | Substantially Equivalent |
| K102537 | APTUS 1.5 TRILOCK | Dec 10, 2010 | Substantially Equivalent |