Exactech, Inc.
Exactech, Inc. holds FDA 510(k) medical device clearances, first cleared 1986, most recent 2026, with 211 FDA device recalls on record.
Clearances by Exactech, Inc. — page 2
101–186 of 186- K082022 — OPTETRAK 9MM CRUCIATE RETAINING TIBIAL INSERT, SLOPE ++
- K080980 — EXACTECH NOVATION ELEMENT PRESS-FIT FEMORAL STEMS
- K073688 — EQUINOXE REVERSE SHOULDER SYSTEM FRACTURE HUMERAL ADAPTER TRAY AND LOCKING SCREW
- K071738 — EXACTECH OPTETRAK PROXIMAL TIBIAL SPACER
- K071676 — EXACTECH NOVATION CROWN CUP CONSTRAINED LINERS AND RINGS
- K063685 — OPTECURE; OPTECURE + CCC
- K070479 — EXACTECH NOVATION CROWN CUP AND LINERS
- K063569 — EQUINOXE REVERSE SHOULDER SYSTEM
- K063279 — NOVATION SPLINED RDD FEMORAL STEMS
- K061668 — OPTECURE +CCC
- K061454 — EXACTECH EQUINOXE SHOULDER STEMS
- K050806 — OPTECURE
- K060107 — MODIFICATION TO: EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS
- K052787 — ACUMATCH 12/14 C-SERIES CEMENTED FEMORAL STEMS (SIZE 1-6), ACUMATCH 12/14 L-SERIES CEMENTED FEMORAL STEMS (SIZE 1-5)
- K051858 — ACUMATCH M-SERIES LPB 12/14 FEMORAL STEM
- K050398 — EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS
- K051556 — ACUMATCH A-SERIES CONNEXION GXL ENHANCED CROSSLINKED POLYTHYLENE
- K051682 — EXACTECH 12/14 ALUMINA FEMORAL HEADS 36 MM
- K051335 — ACUMATCH 12/14 PRESS-FIT FEMORAL STEMS
- K043403 — CEMEX SYSTEM GENTA FAST BONE CEMENT
- K042842 — NOVATION 12/14 PRESS-FIT FEMORAL STEM
- K042021 — EXACTECH EQUINOXE SHOULDER SYSTEM
- K040601 — EXACTECH ACUMATCH A-SERIES & MCS CONSTRAINED ACETABULAR LINERS
- K040889 — EXACTECH OPTETRAK UNICONDYLAR KNEE
- K041906 — EXACTECH 12/14 TOTAL HIP SYSTEM
- K040755 — EXACTECH RESORBABLE ROOM TEMPERATURE BONE PASTE
- K040613 — EXACTECH ACUMATCH A-SERIES AND MCS ACETABULAR SHELLS AND LINERS
- K032522 — TECRES SPACER-K TEMPORARY KNEE PROSTHESIS
- K033596 — CEMEX GENTA BONE CEMENT; CEMEX GENTA SYSTEM BONE CEMENT
- K020078 — EXACTECH RESORBABLE BONE PASTE
- K033883 — OPTETRAK TOTAL KNEE SYSTEM, HI-FLEX ASYMMETRIC POSTERIOR-STABILIZED CEMENTED FEMORAL COMPONENTS, HI-FLEX POSTERIOR-STABI
- K031841 — SPACER G TEMPORARY HIP PROSTHESIS
- K032964 — EXACTECH 12/14 ALUMINA FEMORAL HEAD; EXACTECH ACUMATCH M-SERIES 12/14 NECK SEGMENTS
- K032606 — OPTETRAK TOTAL KNEE SYSTEM ASYMMETRIC FEMORAL COMPONENTS SIZE 6 PSOTERIOR-STABILIZING, CEMENTED FEMORAL COMPONENTS
- K031430 — CEMEX SYSTEM FAST
- K030686 — OPTETRAK TOTAL KNEE SYSTEM - MOLDED METAL-BACK TIBIAL COMPONENT
- K030236 — ACUMATCH P-SERIES POROUS PRESS-FIT FEMORAL COMPONENT
- K023646 — EXATECH ACUMATCH INTEGRATED HIP SYSTEM C-SERIES CEMENTED FEMORAL STEM
- K023186 — OPTETRAK TOTAL KNEE SYSTEM OFFSET TIBIAL TRAY
- K021765 — CEMENT RESTRICTOR, SMALL AND LARGE
- K021715 — CEMEX RX, CEMEX ISOPLASTIC & CEMEX XL
- K020291 — EXACTECH, MODEL PMMA FEMORAL STEM CENTRALIZER
- K013211 — MODIFICATION TO: ACUMATCH L-SERIES BIPOLAR ENDOPROSTHESIS
- K012493 — ACUMATCH C-SERIES CEMENTED FEMORAL COMPONENT, MODEL SIZE 0
- K012251 — OPTETRAK TOTAL KNEE SYSTEM, STRAIGHT STEM EXTENSIONS - ADDITIONAL SIZES
- K011976 — OPTETRAK TOTAL KNEE SYSTEM SIZE 0/1 DELTA (LINE EXTENSION)
- K011218 — ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL SIZE 1
- K011081 — ACUMATCH M-SERIES EXTRA-SMALL METAPHYSEAL SEGMENTS
- K010434 — OPTETRAK B-SERIES TOTAL KNEE SYSTEM
- K010120 — MODIFICATION TO EXACTECH ACUMATCH INTEGRATED HIP SYSTEM, M-SERIES HIGH OFF-SET NECK SEGMENT, M-SERIES LOW OFF-SET NECK S
- K000943 — CEMEX SYSTEM GUN APPLICATION VERSION
- K010081 — ACUMATCH L-SERIES UNIPOLAR ENDOPROSTHESIS
- K002141 — ACUMATCH P-SERIES PRESS-FIT PLASMA, ACUMATCH P-SERIES PRESS-FIT, ACUMATCH L-SERIES PRESS-FIT
- K001335 — ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL L-SERIES CEMENTED
- K000242 — ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT AND ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT WITH HYDROXYAPATITE
- K993736 — EXACTECH ACUMATCH INTEGRATED HIP SYSTEM M-SERIES FEMORAL STEM COMPONENT
- K993082 — EXACTECH ACUMATCH INTEGRATED HIP SYSTEM A-SERIES POROUS COATED ACETABULAR COMPONENT
- K990197 — MODULUS COMPATIBLE STABILITY (MCS)-HA TOTAL HIP SYSTEM
- K964262 — EXACTECH TOTAL HIP SYSTME: 22MM FEMORAL HEAD
- K963313 — EXACTECH ALL POLY ACETABULAR CUP
- K961304 — AURA HIP SYSTEM CEMENTED FEMORAL STEM/CEMENTED LONG FEMORAL STEM
- K962002 — AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM
- K960720 — EXACTECH STERILE MODULAR DRILL BIT
- K960538 — OPTEON UNIPOLAR
- K954208 — OPTETRAK CONSTRAINED CONDYLAR KNEE FOR CEMENTED USE ONLY
- K933494 — EXACTECH POSTERIOR STABILIZED CEMENTED TOTAL KNEE SYSTEM
- K932690 — EXACTECH CRUCIATE RETAINING CEMENTED TOTAL KNEE SY
- K933610 — EXACTECH CEMENTED TOTAL KNEE SYSTEM, TIBIAL COMPONENTS
- K935773 — EXACTECH POROUS COATED POSTERIOR STABILIZED FEMORAL COMPONENT
- K932776 — CRUCIATE RETAINING CEMENTED TIBIAL COMPONENTS
- K935726 — EXACTECH POROUS COATED CRUCIATE RETAINED FEMORAL COMPONENT
- K936079 — ECACTECH POROUS COATED FINNED TIBIAL TRAY COMPNENT
- K931617 — EXACTECH ZIRAMIC FEMORAL HEAD COMPONENT
- K934253 — EXACTECH ALL POLY ACETABULAR CUP
- K921113 — EXATECH MCS POROUS COATED TOTAL HIP FEMORAL STEM
- K921114 — EXACTECH MCS POROUS COATED TOTAL HIP ACETABULAR
- K925201 — EXACTECH FEMORAL STEM
- K914574 — EXACTECH CERAMIC FEMORAL HEAD COMPONENT
- K905577 — EXACTECH HUMERAL SHOULDER PROSTHESIS
- K905580 — TOTAL SHOULDER PROSTHESIS POLYETHYLENE GLENOIND CO
- K905370 — EXACTECH BIPOLAR HIP PROSTHESIS
- K901297 — EXACTECH POROUS COAT TOTAL HIP PROST FEM STEM COMP
- K896601 — EXACTECH BONE SCREW
- K895607 — POROUS COATED TOTAL HIP PROS. ACETABULAR COMPONENT
- K864788 — EXACTECH TOTAL HIP INSTRUMENTS
- K862234 — EXACTECH TOTAL HIP SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.