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

Sofamor Danek Mfg., Inc. · Predicate Candidate Screening

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

268 daysmedian FDA review time
633 days90th percentile
23clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K936294SENTRY(TM) ANTERIOR/POSTERIOR SPINAL SYSTEMSSofamor Danek Mfg., Inc.1995-12-197390
K930191DANEK(TM) SPINAL EPIDURAL ENDOSCOPIC SYSofamor Danek Mfg., Inc.1995-09-269850
K932029TSRH SPINAL SCREWSSofamor Danek Mfg., Inc.1995-01-206330
K922486DANEK TISSUE CUTTING AND REMOVAL SYSTEMSofamor Danek Mfg., Inc.1993-10-125030
K930807SENTRY ANTERIOR SPINAL SYSTEMSofamor Danek Mfg., Inc.1993-10-012270
K930710SENTRY POSTERIOR SPINAL SYSTEMSofamor Danek Mfg., Inc.1993-10-012320
K922543Z-PLATE ANTERIOR FIXATION SYSTEMSofamor Danek Mfg., Inc.1993-05-193550
K923242CROSSLINK AXIAL AND OFFSET PLATESSofamor Danek Mfg., Inc.1993-05-193210
K925811TSRH CENTRAL POST HOOKSSofamor Danek Mfg., Inc.1993-05-182850
K922672AUGMENT POSTERIOR SPINAL FIXATION SYSTEMSofamor Danek Mfg., Inc.1993-05-183480
K921256LUQUE V SPINAL SYSTEMSofamor Danek Mfg., Inc.1993-05-184280
K925577DANEK TISSUE RESECTING SYSTEMSofamor Danek Mfg., Inc.1993-04-081560
K925812TITANIUM SONGER CABLE SYSTEMSofamor Danek Mfg., Inc.1993-03-241320
K920118RESORABPLUGSofamor Danek Mfg., Inc.1993-02-083920
K920546PARAGON POSTERIOR SPINAL SYSTEMSofamor Danek Mfg., Inc.1993-01-213500
K924085RECONSTRUCTION PLATE SYSTEMSofamor Danek Mfg., Inc.1992-12-171260
K923446STERILE DYNA LOK ANTERIOR PLATING SYSTEMSofamor Danek Mfg., Inc.1992-12-171560
K922520MODIFIED TSRH CENTRAL POST HOOKSSofamor Danek Mfg., Inc.1992-11-161780
K922087ANTERIOR CERVICAL PLATE SYSTEMSofamor Danek Mfg., Inc.1992-11-061860
K923339TSRH L CONNECTOR -- MODIFICATIONSofamor Danek Mfg., Inc.1992-10-271250
K914306TSRH(TM) LATERAL OFFSET PLATESofamor Danek Mfg., Inc.1992-06-192680
K914966TSRH CENTRAL POST HOOKSSofamor Danek Mfg., Inc.1992-05-121890
K920201TITANIUM ALLOY SONGER CABLE SYSTEMSofamor Danek Mfg., Inc.1992-04-08840

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