FDA.reportPublic FDA data

NA

Primary DI
00889024311039
Brand
NA
Company
ZIMMER TRABECULAR METAL TECHNOLOGY INC.
Model
00-7040-046-00
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
00889024311039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024311039008890243110398890243110390889024311039

GMDN Terms#

Term, Definition table
TermDefinition
Spinal implant trialA copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.

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
00889024310810NEXGEN®00-5887-056-0000-5887-056-002016-06-20
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840606191302PrimusSPINAL ELEMENTS, INC.HXB2026-09-22
00840606191319PrimusSPINAL ELEMENTS, INC.HXB2026-09-22
00850088713558PRINCETONPrinceton Medical Group, Inc.HXB2026-08-14
B382SD9213821020Surgical DirectSurgical Direct, Inc.HXB2026-08-07
B382SD483800190Surgical DirectSurgical Direct, Inc.HXB2026-08-03
B382SD4838920Surgical DirectSurgical Direct, Inc.HXB2026-08-03
00840606191593Overwatch PCFSPINAL ELEMENTS, INC.HXB2026-07-31
00840606191869Overwatch PCFSPINAL ELEMENTS, INC.HXB2026-07-31
00840606191876Overwatch PCFSPINAL ELEMENTS, INC.HXB2026-07-31
00840183532383BR Surgical, LLCBR Surgical, LLCHXB2026-07-21
18257200046706FIREBIRD SFS,SPECIAL PRODUCTSOrthofix US LLCHXB2026-07-17
05060267134554FORCECORD Passing ProbeXIROS LTDHXB2026-07-06
06974940307830endophixSuzhou Endophix Co., Ltd.HXB2026-06-23
04052536218073uCentumUlrich GmbH & Co. KGHXB2026-06-09
04052536218080uCentumUlrich GmbH & Co. KGHXB2026-06-09
00199150080304Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXB2026-06-05
00846338005474ProbeELLIQUENCE, LLCHXB2026-06-01
04052536085507neon3Ulrich GmbH & Co. KGHXB2026-05-28
07640221373045PERLA ® TLSpineArt SAHXB2026-05-07
08800322758151Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HXB2026-04-21
08800322758168Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HXB2026-04-21
08800017271095BENCOXCorentec Co., LtdHXB2026-04-10
10888857578197Vulcan™ Spinal SystemVB Spine LLCHXB2026-02-20
10888857578203Vulcan™ Spinal SystemVB Spine LLCHXB2026-02-20
10888857578630Vulcan™ Spinal SystemVB Spine LLCHXB2026-02-20
10888857578647Vulcan™ Spinal SystemVB Spine LLCHXB2026-02-20
10888857578654Vulcan™ Spinal SystemVB Spine LLCHXB2026-02-20
10888857578661Vulcan™ Spinal SystemVB Spine LLCHXB2026-02-20
10888857578678Vulcan™ Spinal SystemVB Spine LLCHXB2026-02-20
10888857578685Vulcan™ Spinal SystemVB Spine LLCHXB2026-02-20