FDA.reportPublic FDA data

LINEUM OCT SPINE SYSTEM

Primary DI
00888480511564
Brand
LINEUM OCT SPINE SYSTEM
Company
BIOMET SPINE LLC
Model
14-525054
Catalog number
14-525054
Published
2020-07-07
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
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
MAXIntervertebral fusion device with bone graft, lumbar
MNHOrthosis, spondylolisthesis spinal fixation
MNIOrthosis, spinal pedicle fixation
MQPSpinal vertebral body replacement device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
MQPSpinal Vertebral Body Replacement DeviceOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888480511564PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888480511564008884805115648884805115640888480511564

GMDN Terms#

Term, Definition table
TermDefinition
Manual orthopaedic bender, reusableA manually-operated surgical instrument designed to bend orthopaedic devices, typically those for implantation (e.g., orthopaedic rods, bone fixation plates), to an appropriate anatomical shape. The bending process is typically performed within the operating room (OR), inside or outside of the operative sterile field. The device may be hand held or table mounted. 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)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
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
03662663058254Spine System14-50078114-5007812021-12-17

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07613153046417AVS TLStryker CorporationMAX2015-09-14
07613153046424AVS TLStryker CorporationMAX2015-09-14
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07613153046455AVS TLStryker CorporationMAX2015-09-14