510(k) K011603 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
VHS PEDIATRIC HIP SCREW SYSTEM
| Applicant | Walter Abendschein, M.D., Chevy Chase MD, US |
| Decision | Substantially Equivalent, Aug 15, 2001 |
| Received | May 24, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011603
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 15, 2006 | EBI, L.P. VHS Pediatric Hip Screw System
Ped VHS, Lag Screw
Ref # 200516
Stainless Steel, Rx only Terminated |
KTT | None listed |
| Nov 15, 2006 | EBI, L.P. VHS Pediatric Plate (for hip screw system)
Ref 200501, VHS Pediatric Plate Stainless Steel
Rx only, sterile Terminated |
KTT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.