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

Howmedica Leibinger, Inc. · Predicate Candidate Screening

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

65 daysmedian FDA review time
249 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K970912LEIBINGER SELF-DRILLING SCREWHowmedica Leibinger, Inc.1997-10-012030
K972166GUERRERO - BELL DISTRACTORHowmedica Leibinger, Inc.1997-08-11630
K972154COHEN DISTRACTORHowmedica Leibinger, Inc.1997-08-11630
K961719EPITEC TITANIUM IMPLANT SYSTEM FOR THE SURGICAL ANCHORING OFHowmedica Leibinger, Inc.1997-07-174410
K963030LEIBINGER IMF SCREWHowmedica Leibinger, Inc.1997-04-112490
K970911LEE PLATEHowmedica Leibinger, Inc.1997-04-11300
K963741LEIBINGER LUHR SMALL CRANIOMAXILLOFACIAL BONE SCREWSHowmedica Leibinger, Inc.1997-02-061420
K964649VAZQUEZ DINER INTRAORAL DISTRACTION DEVICEHowmedica Leibinger, Inc.1997-01-24650
K963739LEIBINGER - LUHR SMALL ORTHOPEDIC BONE SCREWSHowmedica Leibinger, Inc.1997-01-221270
K963740LEIBINGER - LUHR SMALL MANDIBULAR BONE SCREWSHowmedica Leibinger, Inc.1996-10-28410
K961120MARKER SYSTEM FOR STEREOTAXIC NAVIGATIONHowmedica Leibinger, Inc.1996-05-10500

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