510(k) K061297 ยท HBB Motor, Drill, Pneumatic
ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM
| Applicant | The Anspach Effort, Inc., Palm Beach Gardens FL, US |
| Decision | Substantially Equivalent, Jan 26, 2007 |
| Received | May 9, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061297
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 9, 2014 | The Anspach Effort, Inc. ***REF IMRI-MOTOR***iMRI Handpiece. Use with iMRI System Only***Rx Only***Manufacturer: The Anspach Effort, Inc. Intended for cutting and shaping bone. Terminated |
HBB | None listed |
| Jul 25, 2012 | The Anspach Effort, Inc. .***ANSPACH***Sterile. REF SHD-4820DS***QTY: 1, 4.8 mm x 2mm Twist Drill with Depth Stop. Use with SHORT-HD Attachment ***RX Only
Product Usage:
Cutting and shaping bone including bones of the spin Terminated |
HTW | None listed |
| Jul 11, 2007 | The Anspach Effort, Inc. Anspach Single Use, Sterile Bone Cutting Burrs Terminated |
HBB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.