510(k) K120633 ยท HBL Holder, Head, Neurosurgical (Skull Clamp)
MAYFIELD SKULL CLAMP
| Applicant | Integra LifeSciences Corporation, Planisboro NJ, US |
| Decision | Substantially Equivalent, May 24, 2012 |
| Received | Mar 1, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120633
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 13, 2013 | Integra LifeSciences Corp. Composite Series Skull Clamp, one clamp per tote.
The MAYFIELD Skull Clamp (A3059) is a cranial stabilization device, designed to provide rigid skeletal fixation. The Skull Clamp is placed on the pa Terminated |
HBL | None listed |
| Dec 19, 2012 | Integra LifeSciences Corporation MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633.
The MAYFIELD Skull Clamps (A3059) are indicated for use in open and percutaneous craniotomies, as well as spinal surgery when rig Terminated |
HBL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.