Company · US

Axya Medical

FDA 510(k) clearances and medical device recalls filed under this name, 1998 to 2007. Name variants (Inc, Corp, punctuation) are merged.

19510(k) clearances (0 in 12 months)

25recalls (0 in 12 months)

21recalls that name a 510(k)

Product codes

Code	Device	Records
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	29
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	5
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	3
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	3
GAB	Needle, Suturing, Disposable	1
JDR	Staple, Fixation, Bone	1
LFL	Instrument, Ultrasonic Surgical	1

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
Oct 11, 2007	K070773	AXYA, MODEL 3000 AXYZLOOP TITANIUM BONE ANCHOR Axya Medical, Inc.	MBI
Jul 11, 2007	K070253	AXYA SUTURE WELDING SYSTEM AND KIT Axya Medical, Inc.	GAT
Dec 4, 2006	K063194	TUFFLEX POLYESTER SUTURE Axya Medical, Inc.	GAT
Sep 1, 2006	K060165	AXYAFLEX POLYESTER SUTURE Axya Medical, Inc.	GAT
Jul 5, 2006	K060970	AXYALOOP NONABSORBABLE BONE ANCHOR Axya Medical, Inc.	JDR
Oct 7, 2005	K052491	AXYA MODEL 6500 AXYALOOP SELF-TAPPING BONE ANCHOR Axya Medical, Inc.	MBI
Aug 5, 2005	K051983	MODEL 3000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR Axya Medical, Inc.	MAI
Jun 9, 2005	K051250	AXYA, MODEL 6500 AXYALOOP BIO-ABSORBABLE BONE ANCHOR Axya Medical, Inc.	MAI
Oct 5, 2004	K041698	AXYA MEDICAL, INC. MODEL 5000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR Axya Medical, Inc.	MAI
Oct 4, 2002	K022207	AXYA MODEL 3000 AXYALOOP TITANIUM BONE ANCHOR SYSTEM Axya Medical, Inc.	MBI
Sep 10, 2002	K021929	AXYA MEDICAL, INC, MODEL 100 SONIC SCALPEL ULTRASONIC SURGICAL SYSTEM Axya Medical, Inc.	LFL
Aug 31, 2001	K011912	MODEL 2000 AXYALOOP SELF-TAPPING BONE ANCHOR, MODEL 2000 Axya Medical, Inc.	MBI
Mar 21, 2001	K003971	AXYA MEDICAL, INC. MODEL 1000 AXYALOOP BONE ANCHOR Axya Medical, Inc.	MBI
Oct 6, 2000	K002557	SUTURE WELDING SYSTEM AND KIT-(J-TIP DESIGN) Axya Medical, Inc.	GAW
Aug 24, 2000	K002435	MODIFICATION TO AXYA MEDICAL, INC. BONE ANCHOR SYSTEM AND KIT (BAK) Axya Medical, Inc.	GAW
Jan 13, 2000	K994313	MODIFICATION TO BONE ANCHOR AND KIT (BAK) Axya Medical, Inc.	GAW
Sep 22, 1999	K992405	AXYA MEDICAL INC, BONE ANCHOR SYSTEM AND KIT- (BAK) Axya Medical, Inc.	GAW
Nov 27, 1998	K983108	SUTURE WELDING SYSTEM AND KIT (SWK) Axya Medical, Inc.	GAW
May 11, 1998	K980988	AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS) Axya Medical, Inc.	GAB

Latest recalls

Date	Firm and product	Code	Linked 510(k)
Dec 8, 2007	Axya Medical Arthrocare 6.5 mm ParaSorb, Preloaded with 2 MagnumWire sutures (1 white/1 co-braid) with needle Part Number:22-5065N, Axya Medical, Inc., Beverly, MA 01915 Terminated	MBI	K051983 K052491 +1
Dec 8, 2007	Axya Medical Arthrocare 6.5 mm ParaSorb, Preloaded with 2 MagnumWire sutures (1 white/1 co-braid), Part Number: 22-5065, Axya Medical, Inc., Beverly, MA 01915 Terminated	MBI	K051983 K052491 +1
Dec 8, 2007	Axya Medical Arthrocare 5.5mm ParaSorb, pre-loaded with 2 MagnumWire sutures (1 white/1 co-braid) with needle Part Number: 22-5055N, Axya Medical, Inc., Beverly, MA 01915 Terminated	MBI	K051983 K052491 +1
Dec 8, 2007	Axya Medical Arthrocare 5.5mm ParaSorb, pre-loaded with 2 MagnumWire sutures (1 white/1 co-braid), Part Number: 22-5055 , Axya Medical, Inc., Beverly, MA 01915 Terminated	MBI	K051983 K052491 +1
Dec 8, 2007	Axya Medical Arthrocare 3.0mm ParaSorb, Preloaded with 2 MagnumWire sutures (1 white/1 co-braid), Part Number: 22-5030, Axya Medical, Inc., Beverly, MA 01915 Terminated	MBI	K051983 K052491 +1
Dec 8, 2007	Axya Medical Arthrocare 6.5mm ParaFix Anchor, 2 strands of MagnumWire Part Number: 22-5012, Axya Medical, Inc., Beverly, MA 01915 Terminated	MBI	K051983 K052491 +1
Dec 8, 2007	Axya Medical Arthrocare 5mm ParaFix Anchor, 2 strands of MagnumWire Part Number: 22-5011, Axya Medical, Inc., Beverly, MA 01915 Terminated	MBI	K051983 K052491 +1
Dec 8, 2007	Axya Medical Arthrocare 3mm ParaFix Anchor, single strand of Magnum Wire,Part Number: 22-5010, Axya Medical, Inc., Beverly, MA 01915 Terminated	MBI	K051983 K052491 +1
Dec 8, 2007	Axya Medical Arthocare 3mm ParaFix Anchor (3mm x 9mm) -single strand of #2 braided suture,Part Number: 22-5002, Axya Medical, Inc., Beverly, MA 01915 Terminated	MBI	K051983 K052491 +1
Dec 8, 2007	Axya Medical Arthocare 5mm ParaFix Anchor (5mm x 14.5mm) -2 strands of #2 braided suture, Part Number: 22-5001, Axya Medical, Inc., Beverly, MA 01915 Terminated	MBI	K051983 K052491 +1
Dec 8, 2007	Axya Medical Axya Bone Anchor 3.0 mm Bioabsorbable in Super Kit Catalog Number: CAT1273, Axya Medical, Inc., Beverly, MA 01915 Terminated	MBI	None listed
Dec 8, 2007	Axya Medical Axya Bone Anchor, 5.0 mm Bioabsorbable in Super Kit, Catalog Number: CAT1271, Axya Medical, Inc., Beverly, MA 01915 Terminated	MBI	K051983 K052491 +1
Dec 8, 2007	Axya Medical Axya Bone Anchor 5.0 mm Bioabsorbable with UHMWPE Suture, Catalog Number: CAT1267, Axya Medical, Inc., Beverly, MA 01915 Terminated	MBI	K051983 K052491 +1
Dec 8, 2007	Axya Medical Axya Bone Anchor 3.0 mm Bioabsorbable with UHMWPE Suture,Catalog Number: CAT1266, Axya Medical, Inc., Beverly, MA 01915 Terminated	MBI	K051983 K052491 +1
Dec 8, 2007	Axya Medical Axya Bone Anchor 6.5 mm Bioabsorbable with Nylon Suture Catalog Number: CAT1265, Axya Medical, Inc., Beverly, MA 01915 Terminated	MBI	K051983 K052491 +1
Dec 8, 2007	Axya Medical Axya Bone Anchor 6.5 mm Bioabsorbable with UHMWPE Suture,Catalog Number: CAT1264, Axya Medical, Inc., Beverly, MA 01915 Terminated	MBI	None listed
Dec 8, 2007	Axya Medical Axya Bone Anchor 5.0 mm Bioabsorbable with Nylon Suture Catalog Number: CAT1234, Axya Medical, Inc., Beverly, MA 01915 Terminated	MBI	K051983 K052491 +1
Dec 8, 2007	Axya Medical Axya Bone Anchor, 3.0 mm Bioabsorbable with Nylon Suture Catalog Number: CAT1230, Axya Medical, Inc., Beverly, MA 01915 Terminated	MBI	None listed
Dec 8, 2007	Axya Medical Axya Bone Anchor 3.0 mm Titanium in Super Kit Catalog Number: CAT1274, Axya Medical, Inc., Beverly, MA 01915 Terminated	MBI	K051983 K052491 +1
Dec 8, 2007	Axya Medical Axya Anchor, 5.0 mm Titanium in Super Kit, Catalog Number: CAT1270, Axya Medical, Inc., Beverly, MA 01915 Terminated	MBI	None listed
Dec 8, 2007	Axya Medical Axya Bone Anchor 5.0 mm Titanium with UHMWPE Suture Catalog Number: CAT1269, Axya Medical, Inc., Beverly, MA 01915 Terminated	MBI	K051983 K052491 +1
Dec 8, 2007	Axya Medical Axya Bone Anchor 3.0 mm Titanium with UHMWPE Suture Catalog Number: CAT1268, Axya Medical, Inc., Beverly, MA 01915 Terminated	MBI	K051983 K052491 +1
Dec 8, 2007	Axya Medical Axya Bone Anchor, 6.5 mm Titanium with Nylon Suture, Catalog Number: CAT1238, Axya Medical, Inc., Beverly, MA 01915 Terminated	MBI	K051983 K052491 +1
Dec 8, 2007	Axya Medical Axya Bone Anchor, 5.0 mm Titanium with Nylon Suture Catalog Number: CAT1227, Axya Medical, Inc., Beverly, MA 01915 Terminated	MBI	K051983 K052491 +1
Dec 8, 2007	Axya Medical Axya Bone Anchor , 3.0 mm Titanium with Nylon Suture Catalog Number: CAT1226, Axya Medical, Inc., Beverly, MA 01915 Terminated		K051983 K052491 +1

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