510(k) K111001 ยท HWC Screw, Fixation, Bone
STERILE STORM (R) OPERATING KIT
| Applicant | Intelligent Orthopaedics, Ltd., Stoke On Trent, Staffordshire, GB |
| Decision | Substantially Equivalent, May 17, 2011 |
| Received | Apr 11, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K111001
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.