FDA.reportPublic FDA data

NA

Primary DI
00889797040617
Brand
NA
Company
WRIGHT MEDICAL TECHNOLOGY, INC.
Model
486102N
Catalog number
486102N
Published
2016-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWIPROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWIProsthesis, Elbow, Hemi-, Radial, PolymerOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889797040617PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889797040617008897970406178897970406170889797040617

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant template, reusableA device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device.

Device Sizes#

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

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
807201207
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00889797023368INVISION600022012016-09-17
00889797023375INVISION600023002016-09-17
00889797023382INVISION600023012016-09-17
00889797023436INVISION600025002016-09-17
00889797023337INVISION600021002016-09-17
00889797023344INVISION600021012016-09-17
00889797023351INVISION600022002016-09-17
00889797107679Made-To-OrderSMS00456SMS004562022-12-08
00889797108188Made-To-OrderSMS00494SMS004942022-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841506148953AlignSKELETAL DYNAMICS L.L.C.KWI2025-12-01
00841506148960AlignSKELETAL DYNAMICS L.L.C.KWI2025-12-01
00850005618034BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618041BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618058BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618065BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618072BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618089BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618249BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618256BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618263BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618287BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618294BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618461BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618478BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618485BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618492BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618508BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618522BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618539 BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618546BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618553BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618560BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618577BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618584BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618591BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618607BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618614BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618621BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618638BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02