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

Advanced Spine Fixation Systems, Inc. — Predicate Candidate Screening

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

194 daysmedian FDA review time
383 days90th percentile
16clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K992012WILTSE SYSTEMAdvanced Spine Fixation Systems, Inc.2000-02-042340
K990845MODIFICATION TO PARTS NUMBERED CGT-SL AND CGT-SL-15Advanced Spine Fixation Systems, Inc.1999-04-13290
K954770CENTRA-LINE GRAPPLE, VARIFIX SYSTEMAdvanced Spine Fixation Systems, Inc.1996-01-251000
K953779SADDLE WITH ANCHOR, STAINLESS STEEL VARIFIX SYSTEMAdvanced Spine Fixation Systems, Inc.1995-11-07850
K953778SADDLE WITH ANCHOR, TITANIUM VARIFIX SYSTEMAdvanced Spine Fixation Systems, Inc.1995-11-06840
K953369STAINLESS STEEL VARIFIX SYSTEM 5.0MM DIAMETER ANCHOR SCREWAdvanced Spine Fixation Systems, Inc.1995-09-08520
K9513085.8MM DIAMETER ANCHOR SCREWAdvanced Spine Fixation Systems, Inc.1995-07-261260
K951172TITANIUM LOW PROFILE CROSS BARAdvanced Spine Fixation Systems, Inc.1995-07-251320
K943775SELBY INSTRUMENTATIONAdvanced Spine Fixation Systems, Inc.1995-04-262670
K945064SELBY INSTRUMENTATIONAdvanced Spine Fixation Systems, Inc.1995-04-261940
K942387SELBY INSTRUMENTATIONAdvanced Spine Fixation Systems, Inc.1995-02-142710
K931225LOW PROFILE MID CROSS BRACINGAdvanced Spine Fixation Systems, Inc.1994-05-024180
K931208LOW PROFILE SLEAVE NUT ASSEMBLYAdvanced Spine Fixation Systems, Inc.1994-03-283830
K924474SELBY INSTRUMENTATIONAdvanced Spine Fixation Systems, Inc.1993-09-213830
K920102THE SELBY SYSTEMAdvanced Spine Fixation Systems, Inc.1992-05-051170
K884998SELBY INSTRUMENTATIONAdvanced Spine Fixation Systems, Inc.1989-06-222020

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