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

Advanced Med/Surg, Inc. — Predicate Candidate Screening

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

155 daysmedian FDA review time
450 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K942108COHORT BONE BRUSHAdvanced Med/Surg, Inc.1994-10-111620
K931538AMSET(TM) CANNULATED BONE SCREWAdvanced Med/Surg, Inc.1994-05-044010
K921643AMSEN POSTERIOR DISC EVACUATORAdvanced Med/Surg, Inc.1992-06-03580
K921644AMSEN HOCKEY STICK CHISELAdvanced Med/Surg, Inc.1992-06-03580
K921645AMSEN SPINE IMPACTOR INSTRUMENTSAdvanced Med/Surg, Inc.1992-06-03580
K921642AMSEN DOUBLE-ENDED FORAMINAL PROBEAdvanced Med/Surg, Inc.1992-06-03580
K905023AMSET LOCKING PLATE SYSTEMAdvanced Med/Surg, Inc.1992-01-314500
K911768AMSET(TM) BONE SCREWAdvanced Med/Surg, Inc.1991-10-041680
K905014AMSET PLD SYSTEMAdvanced Med/Surg, Inc.1991-04-011460
K903808AMSIS RDS, RADIOGRAPHIC DISCOGRAPHY KITAdvanced Med/Surg, Inc.1991-01-221550

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