FDA applicant
Aesculap Implant System, Inc.
FDA records 18 decisions for Aesculap Implant System, Inc. (Center Valley, PA) from 2007 to 2014: 18 510(k) clearances. Most are in product codes MQP (Spinal Vertebral Body Replacement Device) and NKB (Thoracolumbosacral Pedicle Screw System). Its devices cite 54 predicates, 4 of them its own earlier devices. 4 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Aesculap Implant System, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2014
2026 so far, outlined.
Recalls per year
1in 2020
Class I Class II/III not classified
Planning a device like Aesculap Implant System, Inc.’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) ReportOther applicant names beginning “Aesculap”
FDA records each applicant name separately; these may or may not be the same firm.