FDA applicant
Spinal Concepts, Inc.
FDA records 33 decisions for Spinal Concepts, Inc. (Austin, TX) from 1997 to 2005: 33 510(k) clearances. Most are in product codes MNI (Orthosis, Spinal Pedicle Fixation) and KWQ (Appliance, Fixation, Spinal Intervertebral Body). Its devices cite 42 predicates, 16 of them its own earlier devices. 30 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Spinal Concepts, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Spinal Concepts, Inc. since 2007.
Recalls per year
1in 2010
Class I Class II/III not classified
Planning a device like Spinal Concepts, 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 “Spinal”
FDA records each applicant name separately; these may or may not be the same firm.