Atlas FDA

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

Medicrea Technologies — Predicate Candidate Screening

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

147 daysmedian FDA review time
364 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K102406PASS ANTERIOR SPINAL SYSTEMMedicrea Technologies2011-08-233640
K100544IMPIX LUMBAR INTERBODY DEVICEMedicrea Technologies2010-07-221471
K083798IMPIX ALIF LUMBAR IBF, IMPIX ALIF-D LUMBAR IBF, IMPIX TLIF LMedicrea Technologies2010-05-195132
K100297PASS LP SPINAL SYSTEMMedicrea Technologies2010-03-04300
K083810PASS LP SPINAL SYSTEMMedicrea Technologies2009-07-312210
K083308PASS LP SPINAL SYSTEMMedicrea Technologies2008-12-10300
K082577PASS LP SPINAL SYSTEMMedicrea Technologies2008-10-03280
K082069PASS 2 SPINAL SYSTEMMedicrea Technologies2008-10-03730
K080099PASS SPINAL SYSTEMMedicrea Technologies2008-04-09860
K072226IMPIX SPACERMedicrea Technologies2007-12-101220
K070530MODIFICATION TO PASSMED SPINAL SYSTEMMedicrea Technologies2007-10-182370
K070276MODIFICATION TO PASSMED SPINAL SYSTEMMedicrea Technologies2007-09-212350
K072040C-JAWS CERVICAL COMPRESSIVE MINI FRAMEMedicrea Technologies2007-08-0390
K062181C-JAWS CERVICAL COMPRESSIVE MINI FRAMEMedicrea Technologies2007-01-161690

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