FDA.reportPublic FDA data

LPT

Primary DI
00840420125651
Brand
LPT
Company
WRIGHT MEDICAL TECHNOLOGY, INC.
Model
487A002
Catalog number
487A002
Published
2015-10-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
K864492000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K864492000SWANSON TITANIUM GREAT TOE IMPLANTDow Corning Wright1987-04-15KWD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840420125651PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840420125651008404201256518404201256510840420125651

GMDN Terms#

Term, Definition table
TermDefinition
Partial metatarsophalangeal joint prosthesisA sterile implantable artificial substitute for the distal head of the metatarsal or the adjacent phalangeal base, intended to repair an articulating surface of the metatarsophalangeal (MTP) joint of the foot (toe). The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr)] and implantation may be performed with or without bone cement. The device is intended to treat degenerative or traumatic arthritis, hallux valgus, hallus rigidus, and/or an unstable or painful MTP joint.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7117customerservice@wmt.com

Regulatory Flags#

DUNS number
807201207
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889797076586INVISION60004403600044032022-05-31
00840420167606INVISION600044032016-02-26
00840420106254DARCODC0043162015-10-01
00840420106261DARCODC0043182015-10-01
00840420106278DARCODC0043202015-10-01
00840420106285DARCODC0043222015-10-01
00840420106292DARCODC0043242015-10-01
00889797023443INVISION600025012016-09-17
00889797024136INVISION600124002016-09-17
00889797024143INVISION600124012016-09-17
00889797040686NA49411XL2016-09-17
00889797040693NA49412XL2016-09-17
00889797040709NA49413XL2016-09-17
00889797057295EZ FRAMEEF0037002015-10-24
00889797058452EZ FRAME SIDEKICKEF0016002016-09-17
00889797102957NAEF002550EF0025502022-06-23
00889797103084NAEF003005EF0030052022-06-23
00889797103107NAEF003700EF0037002022-06-23
00889797103091NAEF003010EF0030102022-06-23
00889797103046NAEF001600EF0016002022-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00850061635273Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635280Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635297Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635303Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635310Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635327Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635334Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635341Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635358Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850005618102BioPoly® Lesser Toe Hemiarthroplasty ImplantBiopoly, LLCKWD2023-10-25
00850005618119BioPoly® Lesser Toe Hemiarthroplasty ImplantBiopoly, LLCKWD2023-10-25
00850005618126BioPoly® Lesser Toe Hemiarthroplasty ImplantBiopoly, LLCKWD2023-10-25
00850005618133BioPoly® Lesser Toe Hemiarthroplasty ImplantBiopoly, LLCKWD2023-10-25
00850005618140BioPoly® Lesser Toe Hemiarthroplasty ImplantBiopoly, LLCKWD2023-10-25