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

Centinel Spine, Inc. · Predicate Candidate Screening

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

163 daysmedian FDA review time
203 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Centinel Spine, Inc.2018-05-081950
K152211PCT SystemCentinel Spine, Inc.2015-12-011160
K150053STALIF C; STALIF C-TiCentinel Spine, Inc.2015-06-241630
K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINCentinel Spine, Inc.2015-06-08880
K141942MIDLINE II TICentinel Spine, Inc.2014-11-071130
K142079STALIF CTI, STALIF CCentinel Spine, Inc.2014-10-24850
K133200STALIF C(R)Centinel Spine, Inc.2014-05-082030
K133286MIDLINE (TM)Centinel Spine, Inc.2014-01-09760
K130461STALIF XCentinel Spine, Inc.2013-08-281870
K120819STALIF CCentinel Spine, Inc.2012-08-311650

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