FDA applicant
Surgicraft, Ltd.
FDA records 10 decisions for Surgicraft, Ltd. (Douglassville, PA) from 1997 to 2011: 10 510(k) clearances. Most are in product codes KWP (Appliance, Fixation, Spinal Interlaminal) and MQP (Spinal Vertebral Body Replacement Device). Its devices cite 20 predicates, 3 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Surgicraft, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2011
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Surgicraft, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report