FDA.reportPublic FDA data

NEXGEN®

Primary DI
00889024309739
Brand
NEXGEN®
Company
ZIMMER TRABECULAR METAL TECHNOLOGY INC.
Model
00-5877-011-11
Published
2016-06-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXBPROBE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXBProbeOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024309739PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024309739008890243097398890243097390889024309739

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. 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)348-2759zimmer.consumerrelations@zimmer.com

Regulatory Flags#

DUNS number
793120965
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
00889024223752TM Ardis®96-701-0107196-701-010712016-05-26
00889024223769TM Ardis®96-701-0207196-701-020712016-05-26
00889024223776TM Ardis®96-701-0307196-701-030712016-05-26
00889024223783TM Ardis®96-701-0407196-701-040712016-05-26
00889024223790TM Ardis®96-701-0507196-701-050712016-05-26
00889024223806TM Ardis®96-701-0607196-701-060712016-05-26
00889024223813TM Ardis®96-701-3100196-701-310012016-05-26
00889024316164Mergence™-S96-101-0105196-101-010512017-09-20
00889024316171Mergence™-S96-101-0106196-101-010612017-09-20
00889024316188Mergence™-S96-101-0107196-101-010712017-09-20
00889024316195Mergence™-S96-101-0108196-101-010812017-09-20
00889024316201Mergence™-S96-101-0109196-101-010912017-09-20
00889024316218Mergence™-S96-101-0110196-101-011012017-09-20
00889024316256Mergence™-S96-101-0205196-101-020512017-09-20
00889024316263Mergence™-S96-101-0206196-101-020612017-09-20
00889024316270Mergence™-S96-101-0207196-101-020712017-09-20
00889024316287Mergence™-S96-101-0208196-101-020812017-09-20
00889024316294Mergence™-S96-101-0209196-101-020912017-09-20
00889024316300Mergence™-S96-101-0210196-101-021012017-09-20
00889024316348Mergence™-S96-101-0305196-101-030512017-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640221373045PERLA ® TLSpineArt SAHXB2026-05-07
08800017271095ProbeCorentec Co., LtdHXB2026-04-10
10649111181665Sklar InstrumentsSKLAR CORPORATIONHXB2025-05-29
07640177820631Neo Medical Pedicle Screw SystemNeo Medical SAHXB2023-01-26
07898506815241QuinelatoSchobell Industrial LtdaHXB2023-01-09
07899798204461SchobellSchobell Industrial LtdaHXB2022-12-16
G079C5020010040Golden Isles Pedicle Screw SystemIntelivation, LLCHXB2022-10-26
10649111296673SklarSKLAR CORPORATIONHXB2019-03-19
10649111296932SklarSKLAR CORPORATIONHXB2019-03-19
10649111297120SklarSKLAR CORPORATIONHXB2019-03-19
10649111297496SklarSKLAR CORPORATIONHXB2019-03-19
10649111376351Sklar®SKLAR CORPORATIONHXB2019-02-25
10649111376474Sklar®SKLAR CORPORATIONHXB2019-02-25
10649111377655Sklar®SKLAR CORPORATIONHXB2019-02-25
10649111377785Sklar®SKLAR CORPORATIONHXB2019-02-25
10649111255212Sklar®SKLAR CORPORATIONHXB2019-02-14
10649111255342Sklar®SKLAR CORPORATIONHXB2019-02-14
10649111255502Sklar®SKLAR CORPORATIONHXB2019-02-14
10649111255649Sklar®SKLAR CORPORATIONHXB2019-02-14
10649111176982Sklar®SKLAR CORPORATIONHXB2019-01-24
10649111151477Sklar®SKLAR CORPORATIONHXB2018-11-20
10649111153983Sklar®SKLAR CORPORATIONHXB2018-11-20
10649111155208Sklar®SKLAR CORPORATIONHXB2018-11-20
10649111156847Sklar®SKLAR CORPORATIONHXB2018-11-20
10649111220524Sklar®SKLAR CORPORATIONHXB2018-11-08
10649111220739Sklar®SKLAR CORPORATIONHXB2018-11-08
10649111083389Sklar®SKLAR CORPORATIONHXB2018-10-24
10649111013881Sklar®SKLAR CORPORATIONHXB2018-09-14
10649111018688Sklar®SKLAR CORPORATIONHXB2018-09-14
10649111019470Sklar®SKLAR CORPORATIONHXB2018-09-14