Visualase Anchor Bolt Tools
FHC, INC. · Model 9736537-00908 · UDI-DI 00873263009086
HAO
Prescription
10
510(k) clearances
351
Adverse events
2
Recalls
212
Facilities
Description
Visualase Anchor Bolt Tools (1) Sterilization & Storage Tray (1) Anchor Bolt Driver (1) Anchor Bolt Driver Guide for Stealth Autoguide (1) Anchor Bolt Driver Guide for Leksell Coordinate Frame (1) Anchor Bolt Driver Guide for ROSA ONE Brain (1) Anchor Bolt Driver Guide for CRW Stereotactic System
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2011-04-04 | Zimmer Inc. | A rounded or partially rounded tip on the screwdriver may not provide the required locking torque to lock the closure top to the polyaxial screw. When the hex tip of the screwdrive |
| 2010-07-02 | Integra LifeSciences Corp | Certain NeuroBalloon Catheters have the potential to improperly inflate or deflate under certain conditions. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.