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Bonutti Research, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
17
Inspections
4
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K161628JAS Pulse(TM) Ultrasonic TherapyNovember 10, 2016
K093078UNITY ULTRASONIC SYSTEM WITH PLLA ANCHORSJune 23, 2010
K090175UNITY BETA PLLA SYSTEMSeptember 10, 2009
K082906UNITY BETA ANCHOR SYSTEMOctober 30, 2008
K062820UNITY ALPHA SYSTEMMarch 15, 2007
K060283TRANSET SYSTEMFebruary 22, 2006
K052799MULTITAK 6.0 MM ABSORBABLE ANCHOR SYSTEMDecember 16, 2005
K033717TRANSET FRACTURE FIXATION SYSTEMFebruary 25, 2004
K013177MULTITAK SUTURE SNAP SYSTEMDecember 19, 2001
K012465MULTITAK SPLINTER 3.0 MM RESORBABLE ANCHOROctober 29, 2001
K010479MULTITAK CONICAL TIP BONE SOFT TISSUE SUTURE ANCHORMay 8, 2001
K993115MULTITAK SSDecember 17, 1999
K990156MULTITAK SS BUTTONSMarch 5, 1999
K973015MULTITAK SS SUTURE SYSTEMOctober 9, 1997
K971144MULTITAK SS SUTURE SYSTEMJune 25, 1997
K964532MULTITAK SS SUTURE SYSTEMFebruary 3, 1997
K964324MULTITAK SS SUTURE SYSTEMJanuary 10, 1997