FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SBI LATERAL RHEAD IMPLANT
K Number: K062898
·
Decision Nov 13, 2006
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
32
Applicant Total
20
Review Days
47
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Basic Information
- Device Name
- SBI LATERAL RHEAD IMPLANT
- K Number
- K062898
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3170
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Small Bone Innovations, Inc.
- Date Received
- September 27, 2006
- Decision Date
- November 13, 2006
- Product Code
- KWI
- 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 |
|---|---|---|---|
| KWI | Prosthesis, Elbow, Hemi-, Radial, Polymer | 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 |
| K102180 | RHEAD RADIAL HEAD EXTENDED STEMS | Dec 20, 2010 | 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 |