FDA applicant
Intelligent Implant Systems, LLC
FDA records 6 decisions for Intelligent Implant Systems, LLC (Charlotte, NC) from 2012 to 2018: 6 510(k) clearances. Most are in product codes NKB (Thoracolumbosacral Pedicle Screw System) and HWC (Screw, Fixation, Bone). Since 2016 its 510(k)s took a median of 111 days from receipt to decision, against 84 for FDA’s reviews in the same codes and years. 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 Intelligent Implant Systems, LLC’s devices, and how often a recall has named them.
FDA decisions per year
1in 2018
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2012.
Planning a device like Intelligent Implant Systems, LLC’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 “Intelligent”
FDA records each applicant name separately; these may or may not be the same firm.