Atlas FDA

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

Orthopedic Equipment Co., Inc. — Predicate Candidate Screening

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

20 daysmedian FDA review time
35 days90th percentile
45clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K834035UNIVERSAL SELF-ALIGNING ACETABULAR COMOrthopedic Equipment Co., Inc.1984-06-192090
K841189OEC/REZAIAN SPINAL FIXATOROrthopedic Equipment Co., Inc.1984-05-16570
K800530SCHLEIN TRI-SURFACE ANKLEOrthopedic Equipment Co., Inc.1980-04-02260
K781445SPREADEROrthopedic Equipment Co., Inc.1979-09-274000
K790247TOURNIQUET TEST GAGEOrthopedic Equipment Co., Inc.1979-02-26200
K790209FILTER SYSTEM, ALTNER DISPOSABLEOrthopedic Equipment Co., Inc.1979-02-26270
K781447THREADED ROD CLAMPOrthopedic Equipment Co., Inc.1978-09-27350
K781451FLAT WRENCHOrthopedic Equipment Co., Inc.1978-09-27350
K781449HARRINGTON SPINAL ELEVATOROrthopedic Equipment Co., Inc.1978-09-27350
K781450DRIVERSOrthopedic Equipment Co., Inc.1978-09-27350
K781446C RING CLINCHEROrthopedic Equipment Co., Inc.1978-09-27350
K781448HARRINGTON HOOK CLAMPOrthopedic Equipment Co., Inc.1978-09-27350
K781444OUTRIGGER DISTRACTION UNITOrthopedic Equipment Co., Inc.1978-09-27350
K781443HARRINGTON SPINE INSTRUMENTATIONOrthopedic Equipment Co., Inc.1978-09-27350
K781112CAST WEDGE, YANCEYOrthopedic Equipment Co., Inc.1978-07-17140
K781082CAST BLOCKOrthopedic Equipment Co., Inc.1978-07-0780
K781001CHAIRS WITH CASTORSOrthopedic Equipment Co., Inc.1978-06-30150
K780935GRAB BAROrthopedic Equipment Co., Inc.1978-06-19120
K780684PATIENT LIFTOrthopedic Equipment Co., Inc.1978-06-06430
K780763ENTRAX TRACTION UNITOrthopedic Equipment Co., Inc.1978-05-1680
K780397ORTHOPEDIC FORCEPSOrthopedic Equipment Co., Inc.1978-03-2290
K780398CUP, ACETABULAR, LONG POSTERIOR WALLOrthopedic Equipment Co., Inc.1978-03-2180
K780195WHEELCHAIR MUFFOrthopedic Equipment Co., Inc.1978-03-09340
K780192LEGREST, ELEVATINGOrthopedic Equipment Co., Inc.1978-02-14110
K780191STRAP, LEGRESTOrthopedic Equipment Co., Inc.1978-02-14110
K780194TOE LOOPSOrthopedic Equipment Co., Inc.1978-02-14110
K780193HEEL LOOPSOrthopedic Equipment Co., Inc.1978-02-14110
K780184WHEELCHAIR ACCESSORIESOrthopedic Equipment Co., Inc.1978-02-13100
K780183WHEELCHAIRS, MECHANICALOrthopedic Equipment Co., Inc.1978-02-13100
K780135CEMENT EXTRACTION INSTRUMENT SETOrthopedic Equipment Co., Inc.1978-01-3170
K771888SYRINGE, DISPOSABLEOrthopedic Equipment Co., Inc.1977-10-21160
K770219WATSON-FARRAR TOTAL HIP REPLACEMENTOrthopedic Equipment Co., Inc.1977-02-17140
K770079KESSELL TOTAL SHOULDEROrthopedic Equipment Co., Inc.1977-01-25110
K770080BAKER MOBILE TRACTIONOrthopedic Equipment Co., Inc.1977-01-25110
K770035SCREW, WADSWORTH OLECRANONOrthopedic Equipment Co., Inc.1977-01-1440
K761146SPARBARO TYPE TOTAL HIPOrthopedic Equipment Co., Inc.1976-12-16200
K761036WILSON SPINAL FRAMEOrthopedic Equipment Co., Inc.1976-12-16310
K761150GALLENAUGH BONE PLATESOrthopedic Equipment Co., Inc.1976-12-16200
K760869SPLIT CERVICAL COLLAR/HEAD HALTEROrthopedic Equipment Co., Inc.1976-11-01140
K760868VEST RESTRAINTOrthopedic Equipment Co., Inc.1976-11-01140
K760651TOTAL HIP REPLACEMENT,LAGRANGE-LETOURNELOrthopedic Equipment Co., Inc.1976-10-05200
K760106PROSTHESIS, TOTAL HIP-FEMORALOrthopedic Equipment Co., Inc.1976-07-20260
K760108PROSTHESIS, TOTAL HIP-TEST CUPOrthopedic Equipment Co., Inc.1976-07-20260
K760109PROSTHESIS, TOTAL HIP-RASPOrthopedic Equipment Co., Inc.1976-07-20260
K760107PROSTHESIS, TOTAL HIP-TEST FEMORALOrthopedic Equipment Co., Inc.1976-07-20260

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