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Axya Medical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
19
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K070773AXYA, MODEL 3000 AXYZLOOP TITANIUM BONE ANCHOROctober 11, 2007
K070253AXYA SUTURE WELDING SYSTEM AND KITJuly 11, 2007
K063194TUFFLEX POLYESTER SUTUREDecember 4, 2006
K060165AXYAFLEX POLYESTER SUTURESeptember 1, 2006
K060970AXYALOOP NONABSORBABLE BONE ANCHORJuly 5, 2006
K052491AXYA MODEL 6500 AXYALOOP SELF-TAPPING BONE ANCHOROctober 7, 2005
K051983MODEL 3000 AXYALOOP BIO-ABSORBABLE BONE ANCHORAugust 5, 2005
K051250AXYA, MODEL 6500 AXYALOOP BIO-ABSORBABLE BONE ANCHORJune 9, 2005
K041698AXYA MEDICAL, INC. MODEL 5000 AXYALOOP BIO-ABSORBABLE BONE ANCHOROctober 5, 2004
K022207AXYA MODEL 3000 AXYALOOP TITANIUM BONE ANCHOR SYSTEMOctober 4, 2002
K021929AXYA MEDICAL, INC, MODEL 100 SONIC SCALPEL ULTRASONIC SURGICAL SYSTEMSeptember 10, 2002
K011912MODEL 2000 AXYALOOP SELF-TAPPING BONE ANCHOR, MODEL 2000August 31, 2001
K003971AXYA MEDICAL, INC. MODEL 1000 AXYALOOP BONE ANCHORMarch 21, 2001
K002557SUTURE WELDING SYSTEM AND KIT-(J-TIP DESIGN)October 6, 2000
K002435MODIFICATION TO AXYA MEDICAL, INC. BONE ANCHOR SYSTEM AND KIT (BAK)August 24, 2000
K994313MODIFICATION TO BONE ANCHOR AND KIT (BAK)January 13, 2000
K992405AXYA MEDICAL INC, BONE ANCHOR SYSTEM AND KIT- (BAK)September 22, 1999
K983108SUTURE WELDING SYSTEM AND KIT (SWK)November 27, 1998
K980988AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS)May 11, 1998