Medical Device Manufacturer · US , New York , NY

Small Bone Innovations, Inc.

20 submissions · 20 cleared · Since 2006
20
Total
20
Cleared
0
Denied

Small Bone Innovations, Inc. — FDA 510(k) Submissions

Small Bone Innovations, Inc. has submitted 20 FDA 510(k) premarket notifications since 2006, of which 20 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Screw, Fixation, Bone, Plate, Fixation, Bone, Prosthesis, Elbow, Semi-constrained, Cemented, Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Rod, Fixation, Intramedullary And Accessories . Use the specialty filter in the sidebar to narrow results.

20 devices
1–20 of 20
ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL (A3 INTERLOCKING NAIL)
K130147 · HSB Rod, Fixation,... · Orthopedic
May 2013 101d
ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL(A3 INTERLOCKING NAIL )
K112982 · HSB Rod, Fixation,... · Orthopedic
Apr 2012 179d
RHEAD RADIAL HEAD EXTENDED STEMS
K102180 · JDB Prosthesis, Elbow,... · Orthopedic
Dec 2010 140d
SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, MODEL 100-0061
K092754 · HWC Screw, Fixation, Bone · Orthopedic
Jan 2010 132d
MINI RAIL EXTERNAL FIXATOR SYSTEM
K093550 · KTT Appliance, Fixation,... · Orthopedic
Jan 2010 51d
SBI SR MTP TOE IMPLANT
K073635 · KWD Prosthesis, Toe, Hemi-,... · Orthopedic
Mar 2008 84d
SBI TWISTOFIX
K071541 · HWC Screw, Fixation, Bone · Orthopedic
Sep 2007 97d
SBI FOREFOOT SET
K063635 · HWC Screw, Fixation, Bone · Orthopedic
Aug 2007 266d
SBI ARTFIX
K071656 · HWC Screw, Fixation, Bone · Orthopedic
Aug 2007 90d
SBI TITANIUM THREADED PIN
K071540 · JDW Pin, Fixation, Threaded · Orthopedic
Aug 2007 64d
SBI RHEAD PLATING SYSTEM
K071549 · HRS Plate, Fixation, Bone · Orthopedic
Aug 2007 62d
SBI STAFIX
K071479 · JDR Staple, Fixation, Bone · Orthopedic
Aug 2007 65d
MODIFICATION TO:SBI RINGFIX
K071394 · KTT Appliance, Fixation,... · Orthopedic
Jun 2007 39d
SBI DISTAL RADIUS VOLAR PLATING SYSTEM
K070793 · HRS Plate, Fixation, Bone · Orthopedic
May 2007 69d
SBI LATERAL RADIO CAPITELLUM
K070236 · JDB Prosthesis, Elbow,... · Orthopedic
Feb 2007 27d
SBI LATERAL RHEAD IMPLANT
K062898 · KWI Prosthesis, Elbow, Hemi-,... · Orthopedic
Nov 2006 47d
SBI CARPAL FUSION PLATE
K062903 · HRS Plate, Fixation, Bone · Orthopedic
Oct 2006 23d
SBI TRIHEDRON MTP HEMI GT
K062040 · KWD Prosthesis, Toe, Hemi-,... · Orthopedic
Oct 2006 76d
SBI ULNAR HEAD IMPLANT
K061146 · KXE Prosthesis, Wrist, Hemi-,... · Orthopedic
Jul 2006 85d
SBI RADIO-CAPITELLAR IMPLANT
K060038 · JDB Prosthesis, Elbow,... · Orthopedic
Mar 2006 83d
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