Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of StrykerLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Small Bone Innovations with 24 510(k) clearances and 3 device recalls. The most recent is a device recall dated May 19, 2014: Small Bone Innovations 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Imp….
| May 19, 2014 | Small Bone Innovations 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Implants, and Instruments Indications for Use: AutClass II · Small Bone Innovations (SBi) is recalling all lots of 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Impl | Device recalls |
| May 3, 2013 | ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL (A3 INTERLOCKING NAIL)K130147 · HSB | 510(k) clearances |
| Apr 2, 2012 | ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL(A3 INTERLOCKING NAIL )K112982 · HSB | 510(k) clearances |
| Dec 20, 2010 | RHEAD RADIAL HEAD EXTENDED STEMSK102180 · JDB | 510(k) clearances |
| Jan 19, 2010 | SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, MODEL 100-0061K092754 · HWC | 510(k) clearances |
| Jan 7, 2010 | MINI RAIL EXTERNAL FIXATOR SYSTEMK093550 · KTT | 510(k) clearances |
| Mar 19, 2008 | SBI SR MTP TOE IMPLANTK073635 · KWD | 510(k) clearances |
| Sep 10, 2007 | SBI TWISTOFIXK071541 · HWC | 510(k) clearances |
| Aug 29, 2007 | SBI FOREFOOT SETK063635 · HWC | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
