Atlas FDA

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

Sonoma Orthopedic Products, Inc. · Predicate Candidate Screening

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

190 daysmedian FDA review time
283 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K161371Sonoma Fifth Metatarsal Repair SystemSonoma Orthopedic Products, Inc.2017-02-242830
K142945Sonoma Fibula Repair SystemSonoma Orthopedic Products, Inc.2015-01-221040
K111550SONOMA FASTRAC CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA Sonoma Orthopedic Products, Inc.2011-08-19770
K100112SOMONA CWG CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA CWG Sonoma Orthopedic Products, Inc.2010-09-282570
K092110WAVEON FRACTURE REPAIR SYSTEM (WAVEON RX)Sonoma Orthopedic Products, Inc.2010-01-201900
K090304WAVEON WRX BONE FIXATION SYSTEMSonoma Orthopedic Products, Inc.2009-08-282030
K081832ENSPLINTCMX CLAVICLE PINSonoma Orthopedic Products, Inc.2008-10-101050
K080778ENSPLINT TM BONE SCREWSonoma Orthopedic Products, Inc.2008-07-101130
K071809ENSPLINTRX BONE FIXATION SYSTEMSonoma Orthopedic Products, Inc.2008-02-212340

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