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

Medicrea International · Predicate Candidate Screening

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

88 daysmedian FDA review time
224 days90th percentile
17clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International2022-04-19290
K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International2022-04-08250
K180091UNiD Spine AnalyzerMedicrea International2018-02-08270
K170172UNiD Spine AnalyzerMedicrea International2017-05-241250
K153169PASS OCT Patient Specific RodsMedicrea International2016-01-29880
K150049PASS LP Spinal SystemMedicrea International2015-02-10290
K140738PASS LP SPINAL SYSTEMMedicrea International2014-11-042240
K133906C-JAWS CERVICAL COMPRESSIVE STAPLEMedicrea International2014-07-242130
K132395LIGAPASSMedicrea International2013-12-061270
K132574PASS LP SPINAL SYSTEMMedicrea International2013-11-08840
K132575PASS LP SPINAL SYSTEMMedicrea International2013-10-03480
K121979PASS OCT SPINAL SYSTEMMedicrea International2013-03-212580
K123138PASS LP SPINAL SYSTEMMedicrea International2013-02-051230
K121323MEDICREA INTERNATIONAL ANTERIOR LUMBAR PLATEMedicrea International2012-07-18770
K112736PASS LP SPINALMedicrea International2012-02-011340
K112493PASS LP SPINAL SYSTEMMedicrea International2011-11-21840
K110497PASS LP SPINAL SYSTEMMedicrea International2011-09-262161

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