Medical Device Manufacturer · US , New York , NY

Small Bone Innovations, Inc. - FDA 510(k) Cleared Devices

20 submissions · 20 cleared · Since 2006

Recent clearances: ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL (A3 INTERLOCKING NAIL), ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL(A3 INTERLOCKING NAIL ), RHEAD RADIAL HEAD EXTENDED STEMS

20

Total

20

Cleared

0

Denied

FDA 510(k) Regulatory Record - Small Bone Innovations, Inc. Orthopedic ✕

20 devices

1-12 of 20

Cleared May 03, 2013

ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL (A3 INTERLOCKING NAIL)

Orthopedic · 101d

Cleared Apr 02, 2012

ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL(A3 INTERLOCKING NAIL )

Orthopedic · 179d

Cleared Dec 20, 2010

RHEAD RADIAL HEAD EXTENDED STEMS

Orthopedic · 140d

Cleared Jan 19, 2010

SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, MODEL 100-0061

Orthopedic · 132d

Cleared Jan 07, 2010

MINI RAIL EXTERNAL FIXATOR SYSTEM

Orthopedic · 51d

Cleared Mar 19, 2008

SBI SR MTP TOE IMPLANT

Orthopedic · 84d

Cleared Sep 10, 2007

Orthopedic · 97d

Cleared Aug 29, 2007

SBI FOREFOOT SET

Orthopedic · 266d

Cleared Aug 27, 2007

Orthopedic · 90d

Cleared Aug 08, 2007

SBI TITANIUM THREADED PIN

Orthopedic · 64d

Cleared Aug 07, 2007

SBI RHEAD PLATING SYSTEM

Orthopedic · 62d

Cleared Aug 02, 2007

Orthopedic · 65d