Atlas FDA

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

Terray Manufacturing, Inc. — Predicate Candidate Screening

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

74 daysmedian FDA review time
339 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K910874THORACIC ANTERIOR SPINAL FIXATION PLATETerray Manufacturing, Inc.1992-02-033390
K882934CASF CANCELLOUS BONE SCREW, BT650Terray Manufacturing, Inc.1988-10-13920
K882871CASF DRILL GUIDE DG 170Terray Manufacturing, Inc.1988-09-23740
K883193CASF STERILIZATION TRAYTerray Manufacturing, Inc.1988-08-10130
K883125CASF STERILIZATION TRAYTerray Manufacturing, Inc.1988-08-10150
K870085ANTERIOR SPINAL FIXATION PLATETerray Manufacturing, Inc.1987-06-301730
K870082BONE PLATETerray Manufacturing, Inc.1987-05-061180
K870083FERRAY EXTRACTORTerray Manufacturing, Inc.1987-02-26490
K870084RD 140 SURGICAL BENDERTerray Manufacturing, Inc.1987-01-28200

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