Product code KWS— Orthopedic
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
- Classification name
- Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- Device class
- Class 2
- Regulation
- 21 CFR 888.3660
- Advisory panel
- Orthopedic
- Total cleared
- 191
- First cleared
- Most recent
Clearances under product code KWS — page 2
101–191 of 191- K103419 — EXACTECH EQUINOXE R UHMWPE POSTERIOR AUGMENT PEGGED GLENOIDS TM
- K093599 — ARROW ANATOMICAL SHOULDER SYSTEM
- K103104 — SPECIAL ORTHOPAEDIC SOLUTIONS GLENOID SHOULDER COMPONENT
- K103007 — AFFINITI TOTAL AND HEMI-SHOULDER SYSTEM
- K093430 — EXACTECH EQUINOXE XL KEELED GLENOID, PEGGED GLENOID, EXACTECH EQUINOXE CAGE, GLENOID CONTD.
- K100448 — ASCENSION MODULAR TOTAL SHOULDER SYSTEM
- K091196 — GRS GLENOID RESURFACING SYSTEM
- K092122 — GLOBAL SHOULDER STEPTECH ANCHOR PEG GLENOID
- K091751 — DEPUY DELTA XTEND REVERSE SHOULDER XLK CUP
- K083435 — ARTHREX UNIVERS II SHOULDER PEGGED GLENOID
- K082120 — AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS
- K081707 — AEQUALIS SHOULDER FRACTURE AND SHOULDER SYSTEMS
- K081620 — MODIFICATION TO DEPUY DELTA XTEND REVERSE SHOULDER SYSTEM
- K080402 — ENCORE SHOULDER PRIMARY HUMERAL STEM, MODEL 500-00, ENCORE SHOULDER HUMERAL HEAD, MODEL 520-38
- K071032 — ARTHREX UNIVERS II SHOULDER PROSTHESIS
- K071090 — TRABECULAR METAL GLENOID- B/F COMPLETE SHOULDER SOLUTION
- K060694 — MODULAR HYBRID GLENOID
- K060988 — TOTAL AND HEMI SHOULDER SYSTEM
- K062029 — ANATOMICAL SHOULDER FRACTURE SYSTEM
- K062113 — SOLAR REUNION FRACTURE STEM
- K060874 — DEPUY GLOBAL AP SHOULDER SYSTEM
- K060209 — AEQUALIS SHOULDER FRACTURE SYSTEM & AEQUALIS SHOULDER SYSTEM
- K052472 — DEPUY GLOBAL SHOULDER CROSSLINK GLENOID
- K051623 — ANATOMICAL SHOULDER KEELED GLENOID
- K043346 — GENESIS TOTAL SHOULDER REPLACEMENT, MODEL 100-01-00
- K043077 — MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM; AEQUALIS SHOULDER SYSTEM
- K043061 — THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4316-XX-XX
- K042021 — EXACTECH EQUINOXE SHOULDER SYSTEM
- K041339 — AEQUALIS SHOULDER SYSTEM
- K040610 — VERSA-DIAL HUMERAL HEAD
- K033506 — COMPREHENSIVE HUMERAL FRACTURE POSITIONING SLEEVE
- K032679 — AEQUALIS SHOULDER FRACTURE SYSTEM
- K031449 — MODIFICATION TO THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION
- K030259 — AMATOMICAL SHOULDER WITH REMOVABLE HEAD
- K030344 — MODULAR NEER 3 HUMERAL STEMS AND MODULAR NEER 3 HUMERAL HEADS
- K020345 — ARTHREX UNIVERS FRACTURE PROSTHESIS
- K012788 — VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UNMWPE COMPONENTS IN THE COFIELD TOTAL SHOULDER SYSTEM, THE NEER II
- K012378 — 3D HUMERAL HEADS
- K003324 — PLASMA SPRAYED SHOULDER
- K012212 — MODIFICATION TO AEQUALIS SHOULDER SYSTEM
- K010124 — ARTHREX UNIVERS 30 SHOULDER PROSTHESIS
- K003801 — ANATOMICAL PRESS-FIT HUMERAL STEM
- K003566 — COFIELD ECCENTRIC AND LATERAL OFFSET HUMERAL HEADS
- K003832 — SULZER ORTHOPEDICS ANATOMICAL SHOULDER CEMENTED HUMERAL STEM
- K003728 — MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM
- K002683 — WMT ULTRA-FIT MODULAR SHOULDER SYSTEM
- K001706 — WMT MODULAR SHOULDER SYSTEM
- K994393 — AEQUALIS UNIVERSAL SHOULDER GLENOID
- K001046 — BIOPRO GLENOID COMPONENT W/ KEEL & W/ POSTS
- K994350 — NEER III TOTAL SHOULDER SYSTEM
- K000575 — GLOBAL ADVANTAGE EXTENDED HUMERAL HEAD
- K994392 — AEQUALIS SHOULDER FRACTURE SYSTEM
- K992899 — BIO-MODULAR SHOULDER OFFSET HUMERAL HEADS
- K992119 — BIO-MODULAR SHOULDER SYSTEM
- K980244 — AEQUALIS SHOULDER PROSTHESIS
- K992065 — GLOBAL ADVANTAGE SHOULDER, GLOBAL ADVANTAGE HUMERAL STEM, GLOBAL ADVANTAGE ECCENTRIC HEAD
- K990598 — OSTEONICS SOLAR SHOULDER HUMERAL BEARING HEAD
- K990136 — ANATOMICA GLENOID COMPONENT
- K990137 — ANATOMICA HUMERAL STEM/HEAD COMPONENTS
- K981487 — DEPUY GLOBAL SHOULDER GLENOID
- K974044 — GLOBAL TOTAL SHOULDER ECCENTRIC HUMERAL HEAD
- K971715 — SELECT SHOULDER OFFSET HUMERAL HEAD COMPONENTS
- K962224 — SELECT SHOULDER CONCENTRIC HUMERAL HEAD COMPONENTS
- K962082 — OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT
- K960906 — FOUNDATION GLENOID COMPONENT
- K955944 — OSTEONICS N2/VAC PACKAGING PROCESS
- K955767 — COFIED MODULAR SHOULDER SYSTEM
- K955731 — OSTEONICS SHOULDER HUMERAL COMPONENTS
- K952928 — AEQUALIS SHOULDER SYSTEM FOR TOTAL & HEMISHOULDER APPLICATIONS
- K950521 — OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT
- K950651 — TOTAL SHOULDER PROSTHESIS
- K935802 — SELECT(R) SHOULDER ALL POLY GLENOID
- K943300 — DEPUY POROUS COATED GLOBAL SHOULDER
- K920362 — 3M MODULAR SHOULDER SYSTEM
- K904879 — BEUCHEL-PAPPAS GLENOID COMPONENT
- K904880 — BUECHEL-PAPPAS HUMERAL STEM COMPONENT
- K903886 — OSTEONICS SR GLENOID COMPONENTS
- K902855 — NEW JERSEY TOTAL SHOULDER GLENOID COMPONENT
- K901434 — PAPILLOTOME
- K895226 — NEER II TOTAL SHOULDER SYSTEM & PROSTHESIS
- K884943 — INTERMEDICS SELECT SHOULDER METAL-BACKED GLENOID
- K883816 — SHOULDER MICROSTRUCTURED HUMERAL PROSTHESIS
- K881750 — NORMAL HUMERAL PROSTHESIS
- K881836 — INTERMEDICS SELECT SHOULDER ALL PLASTIC GLEN. COMP
- K870262 — FENLIN II SHOULDER PROSTHESIS
- K862535 — OSTEONICS SHOULDER PROSTHESIS
- K855183 — COFIELD SHOULDER SYSTEM
- K852365 — LINK SHOULDER PROSTHESIS ENDO-MODEL SYSTEM
- K843624 — COFIELD SHOULDER SYSTEM
- K833410 — MONOSPHERICAL GLENOID PROSTH. KEEL
- K801970 — UCLA SHOULDER
Data sourced from openFDA. This site is unofficial and independent of the FDA.