Product Code: KWD


Products Classified as KWD

4562Prosthesis, Toe, Hemi-, PhalangealToe Joint Phalangeal (hemi-toe) Polymer Prosthesis.

Total Product Life Cycle (TPLC) Devices

4562Prosthesis, Toe, Hemi-, PhalangealToe Joint Phalangeal (hemi-toe) Polymer Prosthesis.

FDA Consensus Standards

Prosthesis, Toe, Hemi-, Phalangeal [37410]21 CFR §888.3730 🔎
Prosthesis, Toe, Hemi-, Phalangeal [37411]21 CFR §888.3730 🔎
Prosthesis, Toe, Hemi-, Phalangeal [35610]21 CFR §888.3730 🔎

Pre-market Notifications for KWD

K203634BioPoly Great Toe Hemiarthroplasty ImplantBioPoly, LLC
K201393Restor3d MTP ImplantRestor3d, Inc.
K200951Accu-Joint Hemi ImplantAccufix Surgical, Inc.
K190543Cannulated Hemi ImplantVilex In Tennessee, Inc.
K190261BOSS Toe Fixation SystemArthrosurface, Inc.
K161279Life Spine Metatarsal Hemi ImplantLIFE SPINE INC.
K152454HemiCAP MTP Resurfacing Hemi-Arthroplasty SystemARTHROSURFACE, INC.
K131377HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANTARTHROSURFACE, INC.
K131187LESSER METATARSAL HEAD IMPLANT SYSTEMSOLANA SURGICAL, LLC
K121973BIOPRO HEMI-EDGE TOE SYSTEMBIOPRO, INC.
K120029HEMI PHALANGEAL IMPLANT SURGICAL INSTRUMENT SETSOLANA SURGICAL LLC
K113752METATARSAL DECOMPRESSION IMPLANT SURGICAL INSTRUMENT SETSOLANA SURGICAL LLC
K102401HEMI IMPLANT; MINI HEMI IMPLANTVILEX, INC.
K092047ASCENSION METAL GREAT TOE SYSTEMASCENSION ORTHOPEDICS, INC.
K090127METATARSAL DECOMPRESSION IMPLANT, MODEL 100SOLANA SURGICAL LLC

Global Unique Device Identification Database

00812926020105Prosthesis, Toe, Hemi-, Phalangeal
00812926020099Prosthesis, Toe, Hemi-, Phalangeal
00812926020082Prosthesis, Toe, Hemi-, Phalangeal
00812926020075Prosthesis, Toe, Hemi-, Phalangeal
00852897002038Prosthesis, Toe, Hemi-, Phalangeal
00852897002021Prosthesis, Toe, Hemi-, Phalangeal
00845694041041PROSTHESIS, TOE, HEMI-, PHALANGEAL
00845694037013PROSTHESIS, TOE, HEMI-, PHALANGEAL
00845694037006PROSTHESIS, TOE, HEMI-, PHALANGEAL
00845694036993PROSTHESIS, TOE, HEMI-, PHALANGEAL
00845694035859PROSTHESIS, TOE, HEMI-, PHALANGEAL
00845694035828PROSTHESIS, TOE, HEMI-, PHALANGEAL
00845694035811PROSTHESIS, TOE, HEMI-, PHALANGEAL
00845694033022PROSTHESIS, TOE, HEMI-, PHALANGEAL
00845694033015PROSTHESIS, TOE, HEMI-, PHALANGEAL

Maude Adverse Events

CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANTARTHROSURFACE, INC.2019-09-27
HEMICAP? MTP RESURFACING HEMI-ARTHROPLASTYARTHROSURFACE, INC.2019-08-29
HEMICAP? MTP RESURFACING HEMI-ARTHROPLASTYARTHROSURFACE, INC.2019-08-23
FOREFOOT INTERNAL BRACE IMPLANTARTHREX, INC.2019-08-16
CARTIVA IMPLANTWRIGHT MEDICAL TECHNOLOGY, INC.2019-08-02
CARTIVA IMPLANTSWRIGHT TECHNOLOGY, INC.2019-08-02
CARTIVA IMPLANTSWRIGHT MEDICAL TECHNOLOGY, INC.2019-08-02
CARTIVA IMPLANTSCARTIVA, INC.2019-07-31
CARTIVA IMPLANTSCARTIVA, INC.2019-07-31
CARTIVACARTIVA, INC.2019-07-08
HEMICAP? MTP RESURFACING HEMI-ARTHROPLASTY IMPLANTARTHROSURFACE, INC.2019-07-03
HEMICAP? MTP RESURFACING HEMI-ARTHROPLASTY IMPLANTARTHROSURFACE, INC.2019-07-03
3S HEMI IMPLANTTRILLIANT SURGICAL2019-07-02
CARTIVA IMPLANTWRIGHT MEDICAL TECHNOLOGY, INC.2019-06-25
HEMI GREAT TOE IMPLANTOSTEOMED2019-06-12
CARTIVACARTIVA, INC.2019-05-28
CARTIVACARTIVA, INC.2019-05-28
CARTIVACARTIVA2019-05-28
CARTIVACARTIVA, INC.2019-05-28
CARTIVACARTIVA, INC.2019-05-28
CARTIVACARTIVA, INC.2019-05-28
CARTIVACARTIVA, INC.2019-05-28
CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANTARTHROSURFACE, INC.2019-04-04
BIOPRO IMPLANT RIGHT HALLUX AND LONG ARM AUSTIN WITH INTERNAL FIXATION RIGHT FOOBIOPRO, INC.2018-11-30
3S HEMI IMPLANT, SMALL, NON-STERILETRILLIANT SURGICAL2018-11-02
3S HEMI IMPLANT, MEDIUM, NON-STERILETRILLIANT SURGICAL2018-11-02
HEMICAP? MTP RESURFACING HEMI-ARTHROPLASTYARTHROSURFACE, INC.2018-03-30
HEMICAP? MTP RESURFACING HEMI-ARTHROPLASTY IMPLANTARTHROSURFACE, INC.2018-03-28
HEMICAP? MTP RESURFACING HEMI-ARTHROPLASTY IMPLANTARTHROSURFACE, INC.2018-03-02
HEMICAP? MTP RESURFACING HEMI-ARTHROPLASTY IMPLANTARTHROSURFACE, INC.2018-03-02
VILEX HEMI IMPLANTVILEX IN TENNESSEE, INC.2018-02-27
HEMICAP? MTP RESURFACING HEMI-ARTHROPLASTY IMPLANTARTHROSURFACE, INC.2017-12-26
ANATOEMIC, 18.5MMARTHREX INC.2017-11-21
VILEX IMPLANTVILEX IN TENNESSEE, INC.2017-11-15
HEMICAP? MTP RESURFACING HEMI-ARTHROPLASTY IMPLANTARTHROSURFACE, INC.2017-10-25
CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANTARTHROSURFACE, INC.2017-10-17
HEMICAP? MTP RESURFACING HEMI-ARTHROPLASTYARTHROSURFACE, INC.2017-09-14
CAP - GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANTARTHROSURFACE, INC.2017-08-22
CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANTARTHROSURFACE, INC.2017-05-24
CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANTARTHROSURFACE, INC.2017-05-24
PROTHESIS, TOE, HEMI- PHALANGEAL UNIVERSAL HANDLETORNIER INC.2017-04-11
UNKNOWN SMART TOE IMPLANTSTRYKER GMBH2016-10-18
MINI MET HEADVILEX, INC.2016-09-01
VILEX HEMI IMPLANTVILEX, INC.2016-05-27
CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANTARTHROSURFACE, INC.2016-04-06
VILEX MINI METHEADVILEX, INC.2016-03-17
VILEX MINI MET HEADVILEX, INC.2016-01-20
MGT MOVEMENT PROX. PHAL. TOTAL SZ. 40ASCENSION ORTHOPEDICS2016-01-13
HEMICAP? MTP RESURFACING HEMI-ARTHROPLASTY IMPLANTARTHROSURFACE, INC.2015-11-20
CAP 7.0MM MTP RESURFACING HEMI-ARTHROPLASTYARTHROSURFACE2015-11-18
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