FDA.reportPublic FDA data

PROPHECY

Primary DI
00840420185662
Brand
PROPHECY
Company
WRIGHT MEDICAL TECHNOLOGY, INC.
Model
PROPRPT
Catalog number
PROPRPT
Published
2017-03-20
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HNSExpressor
OYKAnkle arthroplasty implantation system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNSExpressorOphthalmic1
OYKAnkle Arthroplasty Implantation SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840420185662PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840420185662008404201856628404201856620840420185662

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made orthopaedic/craniofacial surgical guideA custom-made surgical instrument intended to be used in an orthopaedic and/or craniomaxillofacial procedure (e.g., osteotomy, arthroplasty, tumour resection, distraction osteogenesis, cranial vault reconstruction) to assist in the intraoperative orientation of implant components, outlining the desired cut-line, and/or guiding of surgical instruments (e.g., surgical drill, oscillating cutting saw). It is typically manufactured by 3-D printing and CAD/CAM techniques to match the patient-specific contours of the target anatomical site. This is a single-use device.

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
00889797069298INVISION™60006027600060272022-11-16
00889797103619PROSTEP™ MICA™57790001577900012022-02-01
00889797080392PRO-DENSE LoVisc87SRLV0587SRLV052023-11-21
00889797080415PRO-DENSE LoVisc87SRLV1087SRLV102023-11-21
00889797103589PRO-DENSE LoVisc87SRLV2087SRLV202023-11-21
00889797109796PRO-DENSE LoVisc1420LVGA1420LVGA2023-11-21
00889797076005MINI IGNITE 2.0876P0020876P00202022-08-23
00889797076012MINI IGNITE 2.0876P0040876P00402022-08-23
00889797076036IGNITE 2.0876P0200876P02002022-08-23
00889797076029IGNITE™ 2.0876P0080876P00802022-02-24
00889797072700PRO-DENSE™87SR015087SR01502020-09-08
00889797072717PRO-DENSE™87SR040087SR04002020-09-08
00889797072724PRO-DENSE™87SRCDK087SRCDK02020-09-08
00889797072748PRO-DENSE™87SR002087SR00202020-09-08
00889797072755PRO-DENSE™87SR005087SR00502020-09-08
00889797072762PRO-DENSE™87SR010087SR01002020-09-08
00889797073301PRO-DENSE™87SR007087SR00702020-09-08
00889797073318PRO-DENSE™87SR012087SR01202020-09-08
00840420133434OSTEOSET84000211840002112015-10-15
00840420133465OSTEOSET84000305840003052015-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841731147431OPTIXVILEX LLCOYK2026-03-03
00041533986119BruderThe Hilsinger Company Parent, LlcHNS2026-02-25
00041533986201Bruder LivengoodThe Hilsinger Company Parent, LlcHNS2026-02-25
00041533986300Bruder LivengoodThe Hilsinger Company Parent, LlcHNS2026-02-25
00041533986126Bruder The Hilsinger Company Parent, LlcHNS2025-11-21
00041533986133BruderThe Hilsinger Company Parent, LlcHNS2025-11-21
00041533986102Bruder CollinsThe Hilsinger Company Parent, LlcHNS2025-10-20
00757770402939Bausch + LombBausch & Lomb IncorporatedHNS2025-08-08
00757770418466Bausch + LombBausch & Lomb IncorporatedHNS2025-08-05
00757770418473Bausch + LombBausch & Lomb IncorporatedHNS2025-08-05
00757770429158Bausch + LombBausch & Lomb IncorporatedHNS2025-08-05
00757770433414Bausch + LombBausch & Lomb IncorporatedHNS2025-08-05
00194613101411MSI Precision Specialty InstrumentsMed Saver, Inc.HNS2025-08-01
00194613101428MSI Precision Specialty InstrumentsMed Saver, Inc.HNS2025-08-01
00194613113315MSI Precision Specialty InstrumentsMed Saver, Inc.HNS2025-03-21
00816847022736Salto Talaris Flat Cut Total Ankle System3D SYSTEMS, INC.OYK2025-01-10
00816847022743Salto Talaris Flat Cut Total Ankle System3D SYSTEMS, INC.OYK2025-01-10
00816847022750Salto Talaris Flat Cut Total Ankle System3D SYSTEMS, INC.OYK2025-01-10
00816847022767Cadence Flat Cut Total Ankle System3D SYSTEMS, INC.OYK2025-01-10
00816847022774Cadence Flat Cut Total Ankle System3D SYSTEMS, INC.OYK2025-01-10
00816847022781Cadence Flat Cut Total Ankle System3D SYSTEMS, INC.OYK2025-01-10
00757770419944Bausch + LombBausch & Lomb IncorporatedHNS2024-12-30
00757770535545Bausch + LombBausch & Lomb IncorporatedHNS2024-11-20
00816847022637Cadence Chamfer Cut Total Ankle System3D SYSTEMS, INC.OYK2024-09-12
00816847022651Salto Talaris Chamfer Cut Total Ankle System3D SYSTEMS, INC.OYK2024-09-12
00816847022699Salto Talaris Chamfer Cut Total Ankle System3D SYSTEMS, INC.OYK2024-09-12
00816847022705Salto Talaris Chamfer Cut Total Ankle System3D SYSTEMS, INC.OYK2024-09-12
00816847022712Cadence Chamfer Cut Total Ankle System3D SYSTEMS, INC.OYK2024-09-12
00816847022729Cadence Chamfer Cut Total Ankle System3D SYSTEMS, INC.OYK2024-09-12
00816847022798Vantage 3D PSI3D SYSTEMS, INC.OYK2024-08-05