FDA.reportPublic FDA data

TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM

Primary DI
00880304827493
Brand
TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM
Company
BIOMET SPINE LLC
Model
8615-5010
Catalog number
8615-5010
Published
2016-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAXIntervertebral fusion device with bone graft, lumbar
MDPSeparator for therapeutic purposes, membrane automated blood cell/plasma
MWPCabinet,x-ray system
OVDIntervertebral fusion device with integrated fixation, lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2
MDPSeparator For Therapeutic Purposes, Membrane Automated Blood Cell/PlasmaUnknown3
MWPCabinet, X-Ray SystemRadiology2
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304827493PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304827493008803048274938803048274930880304827493

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)447-3625USBROCustomerService@zimmerbiomet.com

Regulatory Flags#

DUNS number
018577570
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00880304860544Vitality®+ Osteotomy732M2129732M21292018-06-05
00880304860551Vitality®+ Osteotomy732M2221732M22212018-06-05
00880304860568Vitality®+ Osteotomy732M2224732M22242018-06-05
00880304860575Vitality®+ Osteotomy732M2226732M22262018-06-05
00880304860582Vitality®+ Osteotomy732M2229732M22292018-06-05
00888480489450LINEUM OCT SPINE SYSTEM14-52501314-5250132020-10-15
00888480511564LINEUM OCT SPINE SYSTEM14-52505414-5250542020-07-07
00888480207542POLARIS 5.5 SPINAL SYSTEM2000-23252000-23252015-10-24
00880304964143Polaris™ 6.35 Spinal System14-513730R14-513730R2020-11-10
00880304964433Polaris™ 6.35 Spinal System14-513555R14-513555R2020-11-10
03662663058155Spine System14-50077114-5007712021-12-17
03662663058162Spine System14-50077214-5007722021-12-17
03662663058179Spine System14-50077314-5007732021-12-17
03662663058186Spine System14-50077414-5007742021-12-17
03662663058193Spine System14-50077514-5007752021-12-17
03662663058209Spine System14-50077614-5007762021-12-17
03662663058216Spine System14-50077714-5007772021-12-17
03662663058223Spine System14-50077814-5007782021-12-17
03662663058230Spine System14-50077914-5007792021-12-17
03662663058247Spine System14-50078014-5007802021-12-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809974858424Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858431Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858448Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858455Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858462Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858479Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858486Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858493Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858509Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858516Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858523Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858530Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858547Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858554Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858561Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858578Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858585Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858592Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858608Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858615Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858622Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858639Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858646Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858653Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858660Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858677Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858684Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858691Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858707Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858714Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19