FDA.reportPublic FDA data

HUM TR NE +0MM XEXT 40 +3MM RET

Primary DI
00889024688223
Brand
HUM TR NE +0MM XEXT 40 +3MM RET
Company
Zimmer, Inc.
Model
SSI007842
Catalog number
SSI007842
Published
2025-10-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00889024688223PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024688223008890246882238890246882230889024688223

GMDN Terms#

Term, Definition table
TermDefinition
Reverse shoulder cup prosthesis trial, reusableA copy of a final reverse shoulder prosthesis cup designed to be used before primary or revision implant surgery to validate the proper size of the permanent prosthesis required by the patient and to ensure its proper orientation and positioning. It is intended to connect to a reverse shoulder prosthesis/trial prosthesis body and articulates with a reverse shoulder prosthesis/trial prosthesis head; it is typically made of metal and/or polymer. This is a reusable device intended to be sterilized prior to use.

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) 343-9500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
056038268
Device count
1
Premarket exempt
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024702356OsseoFit00-5381-017-1100-5381-017-112026-10-28
00889024702363OsseoFit00-5381-017-1200-5381-017-122026-10-28
00889024702370OsseoFit00-5381-017-1300-5381-017-132026-10-28
00889024702387OsseoFit00-5381-017-1400-5381-017-142026-10-28
00889024702394OsseoFit00-5381-017-1500-5381-017-152026-10-28
00889024702400OsseoFit00-5381-017-1600-5381-017-162026-10-28
00889024702417OsseoFit00-5381-017-2100-5381-017-212026-10-28
00889024702424OsseoFit00-5381-017-2200-5381-017-222026-10-28
00889024702431OsseoFit00-5381-017-2300-5381-017-232026-10-28
00889024702448OsseoFit00-5381-017-2400-5381-017-242026-10-28
00889024702455OsseoFit00-5381-017-2500-5381-017-252026-10-28
00889024702462OsseoFit00-5381-017-2600-5381-017-262026-10-28
00889024702233OsseoFit00-5381-008-0500-5381-008-052026-10-27
00889024702240OsseoFit00-5381-008-0600-5381-008-062026-10-27
00889024702257OsseoFit00-5381-013-0000-5381-013-002026-10-27
00889024702264OsseoFit00-5381-013-1000-5381-013-102026-10-27
00889024702271OsseoFit00-5381-013-1100-5381-013-112026-10-27
00889024702295OsseoFit00-5381-013-1300-5381-013-132026-10-27
00889024702301OsseoFit00-5381-014-0000-5381-014-002026-10-27
00889024702318OsseoFit00-5381-014-0100-5381-014-012026-10-27

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