FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RHEAD RADIAL HEAD EXTENDED STEMS
K Number: K102180
·
Decision Dec 20, 2010
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
26
Applicant Total
20
Review Days
140
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Basic Information
- Device Name
- RHEAD RADIAL HEAD EXTENDED STEMS
- K Number
- K102180
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3160
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Small Bone Innovations, Inc.
- Date Received
- August 2, 2010
- Decision Date
- December 20, 2010
- Product Code
- JDB
- 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 |
|---|---|---|---|
| JDB | Prosthesis, Elbow, Semi-Constrained, Cemented | FDA class 2 | Orthopedic |
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Other Clearances by Small Bone Innovations, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K130147 | ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL (A3 INTERLOCKING NAIL) | May 3, 2013 | Substantially Equivalent |
| K112982 | ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL(A3 INTERLOCKING NAIL ) | Apr 2, 2012 | Substantially Equivalent |
| K092754 | SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, MODEL 100-0061 | Jan 19, 2010 | Substantially Equivalent |
| K093550 | MINI RAIL EXTERNAL FIXATOR SYSTEM | Jan 7, 2010 | Substantially Equivalent |
| K073635 | SBI SR MTP TOE IMPLANT | Mar 19, 2008 | Substantially Equivalent |
| K071541 | SBI TWISTOFIX | Sep 10, 2007 | Substantially Equivalent |
| K063635 | SBI FOREFOOT SET | Aug 29, 2007 | Substantially Equivalent |
| K071656 | SBI ARTFIX | Aug 27, 2007 | Substantially Equivalent |
| K071540 | SBI TITANIUM THREADED PIN | Aug 8, 2007 | Substantially Equivalent |
| K071549 | SBI RHEAD PLATING SYSTEM | Aug 7, 2007 | Substantially Equivalent |