FDA applicant
Precision Surgery, Ltd.
FDA records 4 decisions for Precision Surgery, Ltd. (Chesterland, OH) from 2004 to 2011: 4 510(k) clearances. All are in product code KWQ (Appliance, Fixation, Spinal Intervertebral Body). Its devices cite 4 predicates, 4 of them its own earlier devices. 3 recalls are linked to its devices.
FDA’s records also spell it “Precision Surgery Limited”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Precision Surgery, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2011
2026 so far, outlined.
Recalls per year
1in 2012
Class I Class II/III not classified
Planning a device like Precision Surgery, Ltd.’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