Company ยท US
Small Bone Innovations, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2013. Name variants (Inc, Corp, punctuation) are merged.
24510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HWC | Screw, Fixation, Bone | 6 |
| HRS | Plate, Fixation, Bone | 5 |
| JDB | Prosthesis, Elbow, Semi-Constrained, Cemented | 3 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 3 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 2 |
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | 2 |
| KWI | Prosthesis, Elbow, Hemi-, Radial, Polymer | 2 |
| HTY | Pin, Fixation, Smooth | 1 |
| JDR | Staple, Fixation, Bone | 1 |
| JDW | Pin, Fixation, Threaded | 1 |
| KXE | Prosthesis, Wrist, Hemi-, Ulnar | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 3, 2013 | K130147 | ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL (A3 INTERLOCKING NAIL) Small Bone Innovations, Inc. | HSB |
| Apr 2, 2012 | K112982 | ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL(A3 INTERLOCKING NAIL ) Small Bone Innovations, Inc. | HSB |
| Dec 20, 2010 | K102180 | RHEAD RADIAL HEAD EXTENDED STEMS Small Bone Innovations, Inc. | JDB |
| Jan 19, 2010 | K092754 | SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, MODEL 100-0061 Small Bone Innovations, Inc. | HWC |
| Jan 7, 2010 | K093550 | MINI RAIL EXTERNAL FIXATOR SYSTEM Small Bone Innovations, Inc. | KTT |
| Mar 19, 2008 | K073635 | SBI SR MTP TOE IMPLANT Small Bone Innovations, Inc. | KWD |
| Sep 10, 2007 | K071541 | SBI TWISTOFIX Small Bone Innovations, Inc. | HWC |
| Aug 29, 2007 | K063635 | SBI FOREFOOT SET Small Bone Innovations, Inc. | HWC |
| Aug 27, 2007 | K071656 | SBI ARTFIX Small Bone Innovations, Inc. | HWC |
| Aug 8, 2007 | K071540 | SBI TITANIUM THREADED PIN Small Bone Innovations, Inc. | JDW |
| Aug 7, 2007 | K071549 | SBI RHEAD PLATING SYSTEM Small Bone Innovations, Inc. | HRS |
| Aug 2, 2007 | K071479 | SBI STAFIX Small Bone Innovations, Inc. | JDR |
| Jun 29, 2007 | K071394 | MODIFICATION TO:SBI RINGFIX Small Bone Innovations, Inc. | KTT |
| May 30, 2007 | K070793 | SBI DISTAL RADIUS VOLAR PLATING SYSTEM Small Bone Innovations, Inc. | HRS |
| Feb 21, 2007 | K070236 | SBI LATERAL RADIO CAPITELLUM Small Bone Innovations, Inc. | JDB |
| Nov 13, 2006 | K062898 | SBI LATERAL RHEAD IMPLANT Small Bone Innovations, Inc. | KWI |
| Oct 20, 2006 | K062903 | SBI CARPAL FUSION PLATE Small Bone Innovations, Inc. | HRS |
| Oct 3, 2006 | K062040 | SBI TRIHEDRON MTP HEMI GT Small Bone Innovations, Inc. | KWD |
| Jul 19, 2006 | K061146 | SBI ULNAR HEAD IMPLANT Small Bone Innovations, Inc. | KXE |
| Mar 30, 2006 | K060038 | SBI RADIO-CAPITELLAR IMPLANT Small Bone Innovations, Inc. | JDB |
| Nov 7, 2005 | K052576 | SBI AUTOFIX Small Bone Innovations, LLC | HWC |
| Sep 6, 2005 | K051747 | SBI WRISTFIT Small Bone Innovations, LLC | HRS |
| Aug 10, 2005 | K051605 | SBI K-WIRES Small Bone Innovations, LLC | HTY |
| Apr 26, 2005 | K050462 | SBI HAND FIXATION SYSTEM (TM) Small Bone Innovations, LLC | HRS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 30, 2014 | Small Bone Innovations Small Bone Innovations 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Implants, and Instruments
Indications for Use: AutoFIX" cannu lated screws are indicated for the treatment of fr Terminated |
HWC | K052576 |
| Jun 4, 2014 | Small Bone Innovations, Inc. SBi RingFix Olive Wires
Product Usage: These are temporary devices indicated for: osteosynthesis of fractures with small osteoarticular fragments, fixation of open and closed fractures, arthrodesis, Terminated |
KTT | K071394 |
| Oct 29, 2013 | Small Bone Innovations, Inc. Small Bone Innovations (SBi) rHead Radial Stem, rHead Recon Radial System, rHead Radial Stem Lateral Assembly, rHead Radial Stem 6mm Collar, rHead Recon Radial Stem 6mm Collar, rHead Radial Stem Later Terminated |
KWI | K002644 K010786 +4 |