Small Bone Innovations, Inc.
Small Bone Innovations, Inc. holds FDA 510(k) medical device clearances, first cleared 2006, most recent 2013, with 2 FDA device recalls on record.
Top product codes for Small Bone Innovations, Inc.
FDA recalls by Small Bone Innovations, Inc.
- Z-1720-2014 — 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, sepsis, limb lengthening, and osteotomy.
- Z-0098-2014 — 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 Lateral Assembly 6mm Collar, rHead Standard Extended Stem, rHead Radial Stem Plasma Coated, rHead Recon Radial Stem Plasma Coated, rHead Radial Stem 6mm Collar Plasma Coated, rHead Recon Radial Stem 6mm Collar Plasma Coated, uHead Ulnar Stem Standard, uHead Ulnar Stem 20mm Collar packaged in a sterile pouch inside a shrink-wrapped box. The recall was expanded on December 20, 2013 to include the following devices: rHead lateral assembly, radial head implant, sizes 2 through 4, Uni-elbow lateral assembly, radial implant assembly, sozes 2 through 4, ReMotion Left, large distal radial component, x-small, small, medium, and large, ReMotion Right, distal radial component, x-small, small, medium, and large.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Small Bone Innovations, Inc.
- K130147 — ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL (A3 INTERLOCKING NAIL)
- K112982 — ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL(A3 INTERLOCKING NAIL )
- K102180 — RHEAD RADIAL HEAD EXTENDED STEMS
- K092754 — SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, MODEL 100-0061
- K093550 — MINI RAIL EXTERNAL FIXATOR SYSTEM
- K073635 — SBI SR MTP TOE IMPLANT
- K071541 — SBI TWISTOFIX
- K063635 — SBI FOREFOOT SET
- K071656 — SBI ARTFIX
- K071540 — SBI TITANIUM THREADED PIN
- K071549 — SBI RHEAD PLATING SYSTEM
- K071479 — SBI STAFIX
- K071394 — MODIFICATION TO:SBI RINGFIX
- K070793 — SBI DISTAL RADIUS VOLAR PLATING SYSTEM
- K070236 — SBI LATERAL RADIO CAPITELLUM
- K062898 — SBI LATERAL RHEAD IMPLANT
- K062903 — SBI CARPAL FUSION PLATE
- K062040 — SBI TRIHEDRON MTP HEMI GT
- K061146 — SBI ULNAR HEAD IMPLANT
- K060038 — SBI RADIO-CAPITELLAR IMPLANT
Data sourced from openFDA. This site is unofficial and independent of the FDA.