Atlas FDA

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

Warsaw Orthopedic, Inc. · Predicate Candidate Screening

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

38 daysmedian FDA review time
85 days90th percentile
24clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K892877CRADLE, HOSPITAL BED CLOTHINGWarsaw Orthopedic, Inc.1989-06-15570
K883784TSRH ANTERIOR SPINAL SCREWS, STAPLES AND END PLATEWarsaw Orthopedic, Inc.1989-04-062120
K883783TSRH SACRAL SPINAL SCREWWarsaw Orthopedic, Inc.1989-04-062120
K880211TSRH H/M HOOK HOLDERWarsaw Orthopedic, Inc.1988-03-04450
K880212TSRH H/M HOOK HOLDER W/ROD MOVERWarsaw Orthopedic, Inc.1988-03-04450
K880215TSRH H/M HOOK, EYEBOLT/LOCK NUT ASSEM., SPINAL RODWarsaw Orthopedic, Inc.1988-02-18300
K880214TSRH H/M TORQUE LIMITING WRENCHWarsaw Orthopedic, Inc.1988-02-18300
K870842SCHULTZ PHALANGEAL COMP RASP/METACARPAL COMP RASPWarsaw Orthopedic, Inc.1987-05-27850
K870843SCHULTZ PHALANGEAL COMP TRIAL/METACARPAL COMP TRIAWarsaw Orthopedic, Inc.1987-05-27850
K870830WARSAW ORTHOPEDIC TSR CROSS LINK SYSTEMWarsaw Orthopedic, Inc.1987-05-04620
K870846SCHULTZ MP COMPONENT PUNCHWarsaw Orthopedic, Inc.1987-03-13100
K870847SCHULTZ PHALANGEAL COMPONENT DRIVERWarsaw Orthopedic, Inc.1987-03-13100
K870848SCHULTZ METACARPAL COMPONENT DRIVERWarsaw Orthopedic, Inc.1987-03-13100
K870844SCHULTZ PROSTHESIS COMPONENT INSERTER EXTRACTORWarsaw Orthopedic, Inc.1987-03-13100
K870845WARSAW ORTHOPEDIC POINTED REAMERWarsaw Orthopedic, Inc.1987-03-1180
K870727WARSAW ORTHOPEDIC I BONE PLATEWarsaw Orthopedic, Inc.1987-03-09130
K862311SCREW DRIVER/BONE SCREW WRENCH/TAP & GUIDE PINWarsaw Orthopedic, Inc.1986-07-25380
K862254WARSAW ORTHOPEDIC BONE PLATEWarsaw Orthopedic, Inc.1986-07-08250
K860074SCHULTZ METACARPOPHALANGEAL JOINT PROSTHESISWarsaw Orthopedic, Inc.1986-02-11350
K851919SUPRACONDYLAR BONE PLATEWarsaw Orthopedic, Inc.1985-06-28570
K852026FEMORAL PROXIMAL DIAGNOSAL SCREW, FEMORAL TRANSVERWarsaw Orthopedic, Inc.1985-05-22140
K852020INTERLOCKING FEMORAL NAIL(LEFT & RIGHT) TIBIAL NAIWarsaw Orthopedic, Inc.1985-05-22140
K842293PARTIALLY THREADED BONE FIX. PINWarsaw Orthopedic, Inc.1984-08-02500
K832884FIXATION STAPLE DRIVER/EXTRACTORWarsaw Orthopedic, Inc.1983-10-20550

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