FDA.report

Timberline® MPF Lateral Modular Plate Fixation System

Primary DI
00887868199189
Company
BIOMET SPINE LLC
Model
8615-4516
Catalog number
8615-4516
Published
2020-07-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Regulatory Flags

DUNS number
018577570
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Identifiers

IdentifierTypeAgencyPackage quantityStatus
00887868199189PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
00887868199189PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
MWPCabinet, X-Ray System2Radiology892.1680NEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

TermDefinition
Polymeric spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Device Sizes

TypeValueText
Device Size Text, specify0SPACER MPF PEEK 0DEG 45L X 26W X 16HMM

Storage And Handling

No records found.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)447-3625USBROCustomerService@zimmerbiomet.com

Other Devices From This Company

Primary DIBrandModelCatalogPublished
03662663063234Vital Spinal Fixation System727M54002024-05-10
03662663063241Vital Spinal Fixation System727M55102024-05-10
03662663063258Vital Spinal Fixation System727M64002024-05-10
03662663063265Vital Spinal Fixation System727M65102024-05-10
03662663063272Vital Spinal Fixation System727M74002024-05-10
03662663063289Vital Spinal Fixation System727M75102024-05-10
03662663063296Vital Spinal Fixation System727M84002024-05-10
03662663063302Vital Spinal Fixation System727M85102024-05-10
03662663063524Vital Spinal Fixation System727M54012024-05-10
03662663063531Vital Spinal Fixation System727M54022024-05-10
03662663063548Vital Spinal Fixation System727M55112024-05-10
03662663063555Vital Spinal Fixation System727M55122024-05-10
03662663063562Vital Spinal Fixation System727M64012024-05-10
03662663063579Vital Spinal Fixation System727M64022024-05-10
03662663063586Vital Spinal Fixation System727M65112024-05-10
03662663063593Vital Spinal Fixation System727M65122024-05-10
03662663063609Vital Spinal Fixation System727M74012024-05-10
03662663063616Vital Spinal Fixation System727M74022024-05-10
03662663063623Vital Spinal Fixation System727M75112024-05-10
03662663063630Vital Spinal Fixation System727M75122024-05-10

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
B619X40QF0XPERT40KubtecMWP2025-03-26
B619X42QK0XPERT42KubtecMWP2025-03-26
B619X80LAR0XPERT80LKubtecMWP2025-03-26
B619X80QT0XPERT80KubtecMWP2025-03-26
B619X84R3XPERT84KubtecMWP2025-03-26
00860007231605Clarix Imaging CorpsClarix Imaging CorporationMWP2024-08-01
15420045516656FAXITRON WEDGEHologic, Inc.MWP2023-05-25
06974970580074TrueViewCompAI Healthcare (Suzhou) Co.,ltdMWP2023-05-17
06974970580081TrueViewCompAI Healthcare (Suzhou) Co.,ltdMWP2023-05-17
15420045516625FAXITRON COREHologic, Inc.MWP2023-04-11
15420045516649FAXITRON MAMMOTOMEHologic, Inc.MWP2023-04-11
15420045514898FAXITRON ULTRAFOCUSHologic, Inc.MWP2022-07-12
15420045514911Faxitron CTHologic, Inc.MWP2021-10-07
15420045514836FAXITRON PATHHologic, Inc.MWP2021-08-17
15420045514928Faxitron Path+Hologic, Inc.MWP2021-08-17
15420045515031FAXITRON PATHHologic, Inc.MWP2021-07-30
15420045514218FAXITRON COREHologic, Inc.MWP2021-07-15
06973166110026TrueViewCompAI Healthcare (Shenzhen) Co.,ltdMWP2021-01-22
00887868199110Timberline® MPF Lateral Modular Plate Fixation SystemBIOMET SPINE LLCMWP2020-07-13
00887868199202Timberline® MPF Lateral Modular Plate Fixation SystemBIOMET SPINE LLCMWP2020-07-13
00887868199219Timberline® MPF Lateral Modular Plate Fixation SystemBIOMET SPINE LLCMWP2020-07-13
00887868199226Timberline® MPF Lateral Modular Plate Fixation SystemBIOMET SPINE LLCMWP2020-07-13
00887868199257Timberline® MPF Lateral Modular Plate Fixation SystemBIOMET SPINE LLCMWP2020-07-13
00887868199370Timberline® MPF Lateral Modular Plate Fixation SystemBIOMET SPINE LLCMWP2020-07-13
00887868199431Timberline® MPF Lateral Modular Plate Fixation SystemBIOMET SPINE LLCMWP2020-07-13
00887868199530Timberline® MPF Lateral Modular Plate Fixation SystemBIOMET SPINE LLCMWP2020-07-13
00887868199547Timberline® MPF Lateral Modular Plate Fixation SystemBIOMET SPINE LLCMWP2020-07-13
05060508820017CoreLiteCIRDAN IMAGING LIMITEDMWP2020-03-31
15420045510425TRIDENT HD SPECIMEN RADIOGRAPHYHologic, Inc.MWP2020-03-04
15420045512214TRIDENT HD SPECIMEN RADIOGRAPHYHologic, Inc.MWP2020-03-04