510(k) K932807 ยท HBL Holder, Head, Neurosurgical (Skull Clamp)
MAYFIELD* A-2000 SKULL CLAMP
| Applicant | Ohio Medical Instrument Co., Inc., Cincinnati OH, US |
| Decision | Substantially Equivalent, Sep 28, 1993 |
| Received | Jun 9, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K932807
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 11, 2020 | Integra LifeSciences Corp. Instruction Manual for Mayfield A2000 Skull Cap - Product Usage: intended for or rigid skeletal fixation during neurosurgical procedures. P/N: 451A2000 Terminated |
HBL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.