Panels › Orthopedic › Product code MBI · Class 2
Fastener, Fixation, Nondegradable, Soft Tissue
Regulation 888.3040
33510(k)s in 12 months (607 all time)
0recalls in 12 months (113 all time)
104recalls that name a 510(k)
Top companies in MBI
| Company | 510(k)s | Recalls |
|---|---|---|
| Arthrex, Inc. | 53 | 1 |
| ArthroCare Corporation | 31 | 1 |
| Axya Medical, Inc. | 5 | 24 |
| Smith & Nephew | 23 | 5 |
| Riverpoint Medical | 23 | 1 |
| Parcus Medical | 23 | 0 |
| Innovasive Devices, Inc. | 22 | 0 |
| Biomet, Inc. | 10 | 10 |
| CONMED Corporation | 16 | 1 |
| Stryker | 10 | 6 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
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