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510(k) K200951

Device
Accu-Joint Hemi Implant
Applicant
Accufix Surgical, Inc.
510(k) number
K200951
Product code
KWD  
Decision
Substantially Equivalent (SESE)
Decision date
2020-12-08
Date received
2020-04-09
Regulation
888.3730
Classification name
Prosthesis, Toe, Hemi-, Phalangeal
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Michael Parisi
Address
385 Main St. Suite 10 West Haven CT US 06516 06516

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KWD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250074HYALEX® MTP Hemiarthroplasty ImplantHyalex Orthopaedics, Inc.2026-04-03
K240268Accu-Joint Hemi ImplantAccufix Surgical, Inc.2024-02-29
K221220Montross Extremity Medical Hemi Implant SystemMontross Extremity Medical2023-04-19
K222964BioPoly Lesser Toe Hemiarthroplasty ImplantBioPoly, LLC2022-11-22
K201393restor3d MTP ImplantRestor3D, Inc.2022-05-25
K203634BioPoly Great Toe Hemiarthroplasty ImplantBioPoly, LLC2021-02-02
K190261BOSS Toe Fixation SystemArthrosurface, Inc.2019-08-14
K190543Cannulated Hemi ImplantVilex IN Tennessee, Inc.2019-05-31
K161279Life Spine Metatarsal Hemi ImplantLife Spine, Inc.2017-02-01
K152454HemiCAP MTP Resurfacing Hemi-Arthroplasty SystemArthrosurface, Inc.2016-04-11
K131377HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANTArthrosurface, Inc.2013-11-19
K131187LESSER METATARSAL HEAD IMPLANT SYSTEMSolana Surgical, LLC2013-10-22
K121973BIOPRO HEMI-EDGE TOE SYSTEMBiopro, Inc.2012-10-30
K113752METATARSAL DECOMPRESSION IMPLANT SURGICAL INSTRUMENT SETSolana Surgical, LLC2012-02-06
K120029HEMI PHALANGEAL IMPLANT SURGICAL INSTRUMENT SETSolana Surgical, LLC2012-02-06

Legacy Summary#

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FDA Review#

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