FDA applicant
Spine-Tech, Inc.
FDA records 4 decisions for Spine-Tech, Inc. (Minneapolis, MN) from 1994 to 1998: 4 510(k) clearances. Most are in product codes HRX (Arthroscope) and KWP (Appliance, Fixation, Spinal Interlaminal). 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 Spine-Tech, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Spine-Tech, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Spine-Tech, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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