FDA.reportPublic FDA data

EMPHASYS

Primary DI
10603295537304
Brand
EMPHASYS
Company
DEPUY (IRELAND)
Model
4899-00-001
Catalog number
489900001
Device description
EMPHASYS ACETABULAR X-RAY TEMPLATE
Published
2022-11-23
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
HWTTEMPLATE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295537304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329553730410603295537304

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
989365556
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10603295518761SMARTSET5450-45-5005450455002026-09-10
10603295168324SMARTSET3092-02030920202015-09-24
10603295168331SMARTSET3092-04030920402015-09-24
10603295168355SMARTSET3102-08031020802015-09-24
10603295168362SMARTSET3122-02031220202015-09-24
10603295168379SMARTSET3122-04031220402015-09-24
10603295168614NA3312-04033120402015-09-24
10603295168621NA3322-02033220202015-09-24
10603295168638NA3332-04033320402015-09-24
10603295174264NA5450-31-5005450315002015-09-24
10603295174271NA5450-32-5005450325002015-09-24
10603295174288SMARTSET5450-35-5005450355002015-09-24
10603295174295SMARTSET5450-50-5015450505012015-09-24
10603295202486SMARTMIX CEMVAC83-16038316032018-09-24
10603295541325ATTUNE1518-20-1051518201052021-08-27
10603295541332ATTUNE1518-20-1061518201062021-08-27
10603295541349ATTUNE1518-20-1071518201072021-08-27
10603295541356ATTUNE1518-20-1081518201082021-08-27
10603295541363ATTUNE1518-20-1101518201102021-08-27
10603295541370ATTUNE1518-20-1121518201122021-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024702493OsseoFitZimmer, Inc.HWT2026-10-27
00889024702509OsseoFitZimmer, Inc.HWT2026-10-27
00889024702516OsseoFitZimmer, Inc.HWT2026-10-27
00889024702561OsseoFitZimmer, Inc.HWT2026-10-27
00889024702578OsseoFitZimmer, Inc.HWT2026-10-27
00889024702585OsseoFitZimmer, Inc.HWT2026-10-27
00889024702592OsseoFitZimmer, Inc.HWT2026-10-27
00889024702646OsseoFitZimmer, Inc.HWT2026-10-27
00889024702653OsseoFitZimmer, Inc.HWT2026-10-27
00889795150073APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HWT2026-10-12
10886982350596VOLTSynthes GmbHHWT2026-09-25
10886982350602VOLTSynthes GmbHHWT2026-09-25
10886982350619VOLTSynthes GmbHHWT2026-09-25
10886982350626VOLTSynthes GmbHHWT2026-09-25
10886982350695VOLTSynthes GmbHHWT2026-09-25
10886982350701VOLTSynthes GmbHHWT2026-09-25
10886982350718VOLTSynthes GmbHHWT2026-09-25
00840606191326PrimusSPINAL ELEMENTS, INC.HWT2026-09-22
03701313009502K-RODS.M.A.I.OHWT2026-09-22
00810129551846OvertureTiOverture Resurfacing IncHWT2025-07-23
00810112599534PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599541PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599558PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599565PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599572PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599589PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599596PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599602PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599619PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599626PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12