Medical Device Manufacturer · US , Beverly , MA

Axya Medical, Inc. - FDA 510(k) Cleared Devices

19 submissions · 19 cleared · Since 1998

Recent clearances: AXYA, MODEL 3000 AXYZLOOP TITANIUM BONE ANCHOR, AXYA SUTURE WELDING SYSTEM AND KIT, TUFFLEX POLYESTER SUTURE

19

Total

19

Cleared

0

Denied

FDA 510(k) Regulatory Record - Axya Medical, Inc. Orthopedic ✕

9 devices

1-9 of 9

Cleared Oct 11, 2007

AXYA, MODEL 3000 AXYZLOOP TITANIUM BONE ANCHOR

Orthopedic · 204d

Cleared Jul 05, 2006

AXYALOOP NONABSORBABLE BONE ANCHOR

Orthopedic · 89d

Cleared Oct 07, 2005

AXYA MODEL 6500 AXYALOOP SELF-TAPPING BONE ANCHOR

Orthopedic · 25d

Cleared Aug 05, 2005

MODEL 3000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR

Orthopedic · 14d

Cleared Jun 09, 2005

AXYA, MODEL 6500 AXYALOOP BIO-ABSORBABLE BONE ANCHOR

Orthopedic · 24d

Cleared Oct 05, 2004

AXYA MEDICAL, INC. MODEL 5000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR

Orthopedic · 105d

Cleared Oct 04, 2002

AXYA MODEL 3000 AXYALOOP TITANIUM BONE ANCHOR SYSTEM

Orthopedic · 88d

Cleared Aug 31, 2001

MODEL 2000 AXYALOOP SELF-TAPPING BONE ANCHOR, MODEL 2000

Orthopedic · 73d

Cleared Mar 21, 2001

AXYA MEDICAL, INC. MODEL 1000 AXYALOOP BONE ANCHOR

Orthopedic · 89d