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

Osteomed Corp. — Predicate Candidate Screening

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

112 daysmedian FDA review time
546 days90th percentile
27clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K151021OsteoMed Cannulated Screw SystemOsteomed Corp.2015-07-15900
K022277OSTEOMED CRANIAL FLAP FIXATION SYSTEMOsteomed Corp.2003-04-012600
K022887INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEMOsteomed Corp.2002-11-26880
K022886METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEMOsteomed Corp.2002-11-25870
K0232601.2MM OSTEOMED AUTO-DRIVE SCREW SYSTEMOsteomed Corp.2002-10-18180
K013618INTRAORAL MANDIBULAR DISTRACTION SYSTEMOsteomed Corp.2002-08-142820
K021618OSA RIGID INTERNAL FIXATION SYSTEMOsteomed Corp.2002-08-08840
K012486OSTEOMED BIORESORBABLE FIXATION SYSTEMOsteomed Corp.2002-01-161670
K010964AUTO-DRIVE LAG SCREW SYSTEMOsteomed Corp.2001-07-05970
K0107832.0/2.4 CANNULATED SCREW SYSTEMOsteomed Corp.2001-05-30760
K990944OSTEOMED INTRAORAL DISTRACTION SYSTEMOsteomed Corp.1999-06-16860
K974785AUTO-DRIVE BONE SCREWOsteomed Corp.1998-03-18860
K962774OSTEOMED QUICKFIXOsteomed Corp.1997-10-104510
K971692OSTEOPOWER SYSTEM AND ACCESSORIESOsteomed Corp.1997-06-27510
K963394OSTEOMED TRAMOsteomed Corp.1996-11-14780
K961418OSTEOMED MSSOsteomed Corp.1996-10-251960
K954330SUPER SCREW 3.5 MMOsteomed Corp.1995-12-08840
K932350ORTHOPEDIC SCREW FIXATIONOsteomed Corp.1995-07-057820
K932352ORTHOPEDIC BONE PLATEOsteomed Corp.1995-07-057820
K933101THE OSTEOMED B POWER SYSTEM AND ACCESSORIESOsteomed Corp.1994-11-075010
K932348ORTHOPEDIC SMOOTH PIN FIXATIONOsteomed Corp.1994-03-012910
K932349ORTHOPEDIC THREADED PIN FIXATIONOsteomed Corp.1994-03-012910
K922211OSTEOMED GREAT TOE SYSTEMOsteomed Corp.1993-11-095460
K924018M3 LAG SCREW FIXATION SYSTEMOsteomed Corp.1993-04-012330
K924138OSTEOMED M3 SYSTEM (SBF SYSTEM)Osteomed Corp.1993-02-171830
K911936OSTEOMED SBF SYSTEM (SBF)Osteomed Corp.1991-08-211120
K911937OSTEOMED IB DRILLOsteomed Corp.1991-06-10400

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