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

Lossing Orthopedic, Inc. · Predicate Candidate Screening

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

81 daysmedian FDA review time
112 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K900475DISTRAC(TM) TABLELossing Orthopedic, Inc.1990-05-241120
K864152BACK SAVER LIFT BELT/WHEELCHAIR TRANSFER DEVICELossing Orthopedic, Inc.1987-02-051050
K862874THE TOWERED 90/90 UNITLossing Orthopedic, Inc.1986-08-0780
K843581PROM NAIDLossing Orthopedic, Inc.1984-12-11910
K840551MOBILIZERLossing Orthopedic, Inc.1984-03-23440
K823236BACK ON TRACK INVERSION THERAPY & EXERLossing Orthopedic, Inc.1983-01-21810
K813017NECKTRACLossing Orthopedic, Inc.1981-11-25290
K802555COTTRELL 90/90 BACKTRACLossing Orthopedic, Inc.1980-10-31150

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