FDA applicant
Spectrum Spine IP Holdings, LLC
FDA records 1 decision for Spectrum Spine IP Holdings, LLC (Apple Valley, MN) in 2013: 1 510(k) clearance. All are in product code PEK (Spinous Process Plate). Its devices cite 2 predicates, 0 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 Spectrum Spine IP Holdings, LLC’s devices, and how often a recall has named them.
FDA decisions per year
1in 2013
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2013.
Planning a device like Spectrum Spine IP Holdings, 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 “Spectrum”
FDA records each applicant name separately; these may or may not be the same firm.