Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Suspension Orthopaedic Solutions, LLC · Predicate Candidate Screening

4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K113405SUSPENSION CLAVICLE FRACTURE REPAIR SYSTEMSuspension Orthopaedic Solutions, LLC2012-01-11540
K112923SUSPENSION CLAVICLE FRACTURE FIXATION SYSTEMSuspension Orthopaedic Solutions, LLC2011-12-27850
K102143SUSPENSION ACROMIOCLAVICULAR (AC) REPAIR SYSTEMSuspension Orthopaedic Solutions, LLC2010-12-081310
K102095SUSPENSION CLAVICLE FRACTURE FIXATION SYSTEMSuspension Orthopaedic Solutions, LLC2010-12-071340

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda