FDA applicant
Precision Spine, Inc.
FDA records 26 decisions for Precision Spine, Inc. (Pear, MS) from 2014 to 2025: 26 510(k) clearances. Most are in product codes NKB (Thoracolumbosacral Pedicle Screw System) and KWQ (Appliance, Fixation, Spinal Intervertebral Body). Since 2016 its 510(k)s took a median of 103 days from receipt to decision, against 89 for FDA’s reviews in the same codes and years. Its devices cite 113 predicates, 17 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Precision Spine”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Precision Spine, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2014.
Planning a device like Precision Spine, 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) Report