510(k) K051983 · MAI Fastener, Fixation, Biodegradable, Soft Tissue

MODEL 3000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR

Applicant	Axya Medical, Inc., Beverly MA, US
Decision	Substantially Equivalent, Aug 5, 2005
Received	Jul 22, 2005
Type	Special
FDA record	Open on fda.gov

Recalls that name K051983

Date	Firm and product	Code	Linked 510(k)
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		None listed
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	None listed
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	None listed
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	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	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	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	None listed
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	None listed
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	None listed
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	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	None listed
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	None listed
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	None listed
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	None listed
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	None listed
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	None listed
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	None listed
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	None listed
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	None listed
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	None listed
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	None listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.