FDA.reportPublic FDA data

Cannulated 1st MPJ Hemi Implant

Primary DI
00841731106179
Brand
Cannulated 1st MPJ Hemi Implant
Company
VILEX LLC
Model
CHI-2CH
Device description
Cannulated Hemi Implant #2 17x15 CoCr HA Coated
Published
2016-08-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
KWDProsthesis, Toe, Hemi-, Phalangeal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWDProsthesis, Toe, Hemi-, PhalangealOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102401000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102401000HEMI IMPLANT; MINI HEMI IMPLANTVilex, Inc.2011-07-20KWD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841731106179PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841731106179008417311061798417311061790841731106179

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, non-sterileA small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression. This device must be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
117502293
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841731140395ARTEMIS FUZEAV40-20T-16V2026-07-22
00841731140401ARTEMIS FUZEAV40-22T-16V2026-07-22
00841731140418ARTEMIS FUZEAV40-24T-16V2026-07-22
00841731140425ARTEMIS FUZEAV40-26T-16V2026-07-22
00841731140432ARTEMIS FUZEAV40-28T-16V2026-07-22
00841731140449ARTEMIS FUZEAV40-30T-16V2026-07-22
00841731140456ARTEMIS FUZEAV40-32T-16V2026-07-22
00841731140463ARTEMIS FUZEAV40-34T-16V2026-07-22
00841731140470ARTEMIS FUZEAV40-36T-16V2026-07-22
00841731140487ARTEMIS FUZEAV40-38T-16V2026-07-22
00841731140494ARTEMIS FUZEAV40-40T-16V2026-07-22
00841731140500ARTEMIS FUZEAV40-42T-16V2026-07-22
00841731140517ARTEMIS FUZEAV40-44T-16V2026-07-22
00841731140524ARTEMIS FUZEAV40-46T-16V2026-07-22
00841731140531ARTEMIS FUZEAV40-48T-16V2026-07-22
00841731140548ARTEMIS FUZEAV40-50T-16V2026-07-22
00841731140555ARTEMIS FUZEAV40-52T-16V2026-07-22
00841731140562ARTEMIS FUZEAV40-54T-16V2026-07-22
00841731140593ARTEMIS FUZEAV30-16T-11V2026-07-22
00841731140609ARTEMIS FUZEAV30-18T-11V2026-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G712PN00720100HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN00720120HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN00734100HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN00734120HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN00763100HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN00763120HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN007641HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN00765100HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN00765120HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN00774100HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN00774120HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN00777100HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN00777120HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN007840HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
00810005668095TrigonNVision Biomedical Technologies, Inc.KWD2026-04-24
00810005668101TrigonNVision Biomedical Technologies, Inc.KWD2026-04-24
00810005668118TrigonNVision Biomedical Technologies, Inc.KWD2026-04-24
00810005668187TrigonNVision Biomedical Technologies, Inc.KWD2026-04-24
00810135963565TrigonNVision Biomedical Technologies, Inc.KWD2026-04-24
00810135963572TrigonNVision Biomedical Technologies, Inc.KWD2026-04-24
00850044114962Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635037Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635198Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635204Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635211Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635228Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635235Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635242Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635259Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635266Accu-JointAccufix Surgical, Inc.KWD2024-11-11