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Small Bone Innovations, Inc.

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
24
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2127-2014Class IISmall Bone Innovations 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Implants, and IMay 19, 2014
Z-1720-2014Class IISBi RingFix Olive Wires Product Usage: These are temporary devices indicated for: osteosynthesisApril 7, 2014
Z-0098-2014Class IISmall Bone Innovations (SBi) rHead Radial Stem, rHead Recon Radial System, rHead Radial Stem LateralSeptember 6, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K130147ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL (A3 INTERLOCKING NAIL)May 3, 2013
K112982ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL(A3 INTERLOCKING NAIL )April 2, 2012
K102180RHEAD RADIAL HEAD EXTENDED STEMSDecember 20, 2010
K092754SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, MODEL 100-0061January 19, 2010
K093550MINI RAIL EXTERNAL FIXATOR SYSTEMJanuary 7, 2010
K073635SBI SR MTP TOE IMPLANTMarch 19, 2008
K071541SBI TWISTOFIXSeptember 10, 2007
K063635SBI FOREFOOT SETAugust 29, 2007
K071656SBI ARTFIXAugust 27, 2007
K071540SBI TITANIUM THREADED PINAugust 8, 2007
K071549SBI RHEAD PLATING SYSTEMAugust 7, 2007
K071479SBI STAFIXAugust 2, 2007
K071394MODIFICATION TO:SBI RINGFIXJune 29, 2007
K070793SBI DISTAL RADIUS VOLAR PLATING SYSTEMMay 30, 2007
K070236SBI LATERAL RADIO CAPITELLUMFebruary 21, 2007
K062898SBI LATERAL RHEAD IMPLANTNovember 13, 2006
K062903SBI CARPAL FUSION PLATEOctober 20, 2006
K062040SBI TRIHEDRON MTP HEMI GTOctober 3, 2006
K061146SBI ULNAR HEAD IMPLANTJuly 19, 2006
K060038SBI RADIO-CAPITELLAR IMPLANTMarch 30, 2006