Prophecy

Primary DI
00889797110150
Brand
Prophecy
Company
WRIGHT MEDICAL TECHNOLOGY, INC.
Model
PROP3D
Catalog number
PROP3D
Device description
Prophecy® 3D Planner
Published
2023-04-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSNPROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222835000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222835000Prophecy Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc2023-01-27HSN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889797110150PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889797110150008897971101508897971101500889797110150

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic/craniofacial implantation planning softwareA software program intended to add specific computer-assisted display, processing, and/or analysis capabilities to prepare for the implantation of an orthopaedic and/or craniomaxillofacial (CMF) prosthesis. Using digitized x-rays or imported computed tomography (CT) images, it provides implant-site anatomical images, and using computerized files representing implant patterns, provides the surgeon with images that help determine the appropriate size and placement of the implant.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
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

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
10381780237730Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237747Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237754Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237761Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237778Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237785Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237792Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237808Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237815Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237822Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237839Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237846Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237853Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237860Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237877Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237884Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237891Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237907Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237914Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237921Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237938Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237945Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237952Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237969Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237976Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237983Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237990Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780238003Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780238010Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780238027Cadence™Ascension Orthopedics, Inc.HSN2016-01-12