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Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Sofamor Danek USA,Inc. · Predicate Candidate Screening

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

141 daysmedian FDA review time
365 days90th percentile
41clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K991031COLORADO II SPINAL SYSTEMSofamor Danek USA,Inc.2000-05-104081
K984360COLORADO II SPINAL SYSTEMSofamor Danek USA,Inc.2000-03-304790
K992928CD HORIZON SPINAL SYSTEMSofamor Danek USA,Inc.1999-09-21210
K991036DANEK PLATE AND SCREW SYSTEMSofamor Danek USA,Inc.1999-09-141690
K991198DYNA-LOK PLUS SPINAL SYSTEMSofamor Danek USA,Inc.1999-08-271410
K991364MODIFICATION TO TENOR SPINAL SYSTEM-PLATESSofamor Danek USA,Inc.1999-05-19290
K981676CD HORIZON SPINAL SYSTEMSofamor Danek USA,Inc.1999-01-282610
K980184CD SPINAL SYSTEMSofamor Danek USA,Inc.1998-12-183320
K983672DYNA-LOK SPINAL SYSTEMSofamor Danek USA,Inc.1998-12-16580
K983706MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEMSofamor Danek USA,Inc.1998-11-12220
K982990TSRH SPINAL SYSTEMSofamor Danek USA,Inc.1998-10-21560
K982490TENOR SPINAL SYSTEMSofamor Danek USA,Inc.1998-10-05800
K982686MODIFICATION TO TOWNLEY PEDICLE SCREW PLATING SYSTEMSofamor Danek USA,Inc.1998-08-0740
K963642INCL II ENDOSCOPESofamor Danek USA,Inc.1998-03-185520
K973854ORION ANTERIOR CERVICAL PLATE SYSTEMSofamor Danek USA,Inc.1998-03-161640
K974017TIMESH SYSTEMSofamor Danek USA,Inc.1998-01-16861
K973145TIMESH TITANIUM MINI-SOFTPLATE AND MICRO-SOFT PLATE/SCREW SYSofamor Danek USA,Inc.1997-11-19890
K964159CD SPINAL SYSTEMSofamor Danek USA,Inc.1997-10-163650
K963780DUAL ROD ANTERIOR FIXATOR SYSTEMSofamor Danek USA,Inc.1997-07-303130
K970806ACPII ANTERIOR CERVICAL PLATE SYSTEMSofamor Danek USA,Inc.1997-05-02580
K964254TITANIUM LIBERTY POSTERIOR SPINAL SYSTEMSofamor Danek USA,Inc.1997-04-211790
K965193LIBERTY ANTERIOR SPINAL SYSTEMSofamor Danek USA,Inc.1997-03-17830
K953076TOWNLEY FACET/PEDICULAR SCREW PLATING SYSTEMSofamor Danek USA,Inc.1997-02-286090
K962708TITANIUM CD HORIZON SPINAL SYSTEMSofamor Danek USA,Inc.1997-02-062090
K964623TITANIUM CD HORIZON ANTERIOR SPINAL SYSTEMSofamor Danek USA,Inc.1997-02-06800
K964275ALPHA POSTERIOR SPINAL SYSTEMSofamor Danek USA,Inc.1997-01-14810
K961633CD HORIZON SPINAL SYSTEMSofamor Danek USA,Inc.1996-12-052200
K963655CD HORIZON ANTERIOR SPINAL SYSTEMSofamor Danek USA,Inc.1996-11-27760
K955807COTREL-DUBOUSSET (CD) SPINALSofamor Danek USA,Inc.1996-10-012840
K955365COMPACT COTREL-DUBOUSSET (CCD) SPINAL SYSTEMSofamor Danek USA,Inc.1996-03-271260
K950717AUGMENT-T POSTERIOR SPINAL SYSTEMSofamor Danek USA,Inc.1996-02-143630
K951164CD LIBERTY POSTERIOR SPINCAL SYSTEMSofamor Danek USA,Inc.1996-02-093320
K954645TITANIUM GDLH POSTERIOR SPINAL SYSTEMSofamor Danek USA,Inc.1996-01-16980
K955471INCL ENDOSCOPESofamor Danek USA,Inc.1995-12-18690
K946087INCLUSICE II(TM) ENDOSCOPESofamor Danek USA,Inc.1995-11-213430
K953635TITANIUM DYNA-LOK SPINAL SYSTEMSofamor Danek USA,Inc.1995-10-30890
K950596GDLH POSTERIOR SPINAL SYSTEMSofamor Danek USA,Inc.1995-08-282000
K950955PARAGON POSTERIOR SPINAL SYSTEMSofamor Danek USA,Inc.1995-08-251760
K946348TITANIUM TSRH(R) SPINAL SYSTEM (SCREWS)Sofamor Danek USA,Inc.1995-08-072200
K950501DANEK RIGID ARTHROSCOPESofamor Danek USA,Inc.1995-05-12950
K950130MICRO-ENDO(TM) INSTRUMENTSSofamor Danek USA,Inc.1995-05-011090

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