Atlas FDA

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

Alphatec Mfg., Inc. — Predicate Candidate Screening

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

166 daysmedian FDA review time
513 days90th percentile
20clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K033090ICON POLYAXIAL PEDICLE SCREW SYSTEMAlphatec Mfg., Inc.2004-03-261791
K023299ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEMAlphatec Mfg., Inc.2002-12-11690
K020356ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEMAlphatec Mfg., Inc.2002-07-231690
K993513DELTALOC ANTERIOR CERVICAL PLATE SYSTEMAlphatec Mfg., Inc.2000-04-261910
K993873ALPHATEC EXTERNAL FIXATION SYSTEM COMPRESSION/DISTRACTION ROAlphatec Mfg., Inc.2000-01-03490
K992350PYLON INTRAMEDULLAARY NAIL SYSTEMAlphatec Mfg., Inc.1999-09-22700
K980788ALPHATEC WIRE EXTERNAL FIXATION SYSTEMAlphatec Mfg., Inc.1998-05-22810
K964400ALPHATEC EXTERNAL FIXATION SYSTEMAlphatec Mfg., Inc.1997-04-281750
K951846MIRAGE SPINAL SYSTEM FOR SEVERE SPONDYLOLISTHESISAlphatec Mfg., Inc.1996-02-143000
K926417ALPHATEC 130-150 SLOTTED COMPRESSION HIP SCREWAlphatec Mfg., Inc.1994-09-286440
K930515ALPHA SPINAL SYSTEMAlphatec Mfg., Inc.1994-06-295130
K933112ALPHATEC COMPRESSION AND RECONSTRUCTION PLATESAlphatec Mfg., Inc.1994-02-172370
K925500ALPHATEC 130 COMPRESSION HIP SCREWAlphatec Mfg., Inc.1993-04-141660
K923256ALPHATEC 2.7 MM CANNULATED CORTICAL LAG SCREWAlphatec Mfg., Inc.1992-10-09990
K922166ALPHATEC SMALL FRAGMENT SETAlphatec Mfg., Inc.1992-08-06900
K922167ALPHATEC COMPRESSION AND RECONSTRUCTION PLATESAlphatec Mfg., Inc.1992-08-06900
K922322ALPHATEC 3.5MM ZNNULATED CORTICAL LAG SCREWAlphatec Mfg., Inc.1992-08-05790
K921622ALPHATEC COMPRESSION HIP SCREW SYSTEMAlphatec Mfg., Inc.1992-07-02870
K914004ALPHATEC CANNULATED BONE SCREWSAlphatec Mfg., Inc.1991-12-05900
K894959CYPRESS CERVICAL TRACTION EQUIPMENT, CYPRESS HALOAlphatec Mfg., Inc.1990-09-144030

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