FDA.reportPublic FDA data

LINEUM OCT SPINE SYSTEM

Primary DI
00888480489122
Brand
LINEUM OCT SPINE SYSTEM
Company
BIOMET SPINE LLC
Model
14-524810
Catalog number
14-524810
Published
2016-10-07
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
MNIORTHOSIS, SPINAL PEDICLE FIXATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888480489122PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888480489122008884804891228884804891220888480489122

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

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
07290115935615Counter Torque STPREMIA SPINE LTDMNI2026-05-25
00763000887131CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-03-16
00763000887162CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-03-16
00763000887179CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-03-16
00841732117860PICASSO IICTL Medical CorporationMNI2023-09-07
00841732117877PICASSO IICTL Medical CorporationMNI2023-09-07
00841732117884PICASSO IICTL Medical CorporationMNI2023-09-07
00841732117891PICASSO IICTL Medical CorporationMNI2023-09-07
00841732117907PICASSO IICTL Medical CorporationMNI2023-09-07
00841732117914PICASSO IICTL Medical CorporationMNI2023-09-07
00841732118959PICASSO IICTL Medical CorporationMNI2017-08-08
00841732118966PICASSO IICTL Medical CorporationMNI2017-08-08
00841732118973PICASSO IICTL Medical CorporationMNI2017-08-08
00841732118980PICASSO IICTL Medical CorporationMNI2017-08-08
00841732119017PICASSO IICTL Medical CorporationMNI2017-08-08
00841732119024PICASSO IICTL Medical CorporationMNI2017-08-08
00841732119031PICASSO IICTL Medical CorporationMNI2017-08-08
00841732119048PICASSO IICTL Medical CorporationMNI2017-08-08
00841732119055PICASSO IICTL Medical CorporationMNI2017-08-08
00841732119062PICASSO IICTL Medical CorporationMNI2017-08-08
00841732119079PICASSO IICTL Medical CorporationMNI2017-08-08
088000333846944CIS VANE SPINE SYSTEMALPHA AI CO.,LTD.MNI2016-10-28
088000333847174CIS VANE SPINE SYSTEMALPHA AI CO.,LTD.MNI2016-10-28
088000333847244CIS VANE SPINE SYSTEMALPHA AI CO.,LTD.MNI2016-10-28
088000333847484CIS VANE SPINE SYSTEMALPHA AI CO.,LTD.MNI2016-10-28
088000333847554CIS VANE SPINE SYSTEMALPHA AI CO.,LTD.MNI2016-10-28
088000333847624CIS VANE SPINE SYSTEMALPHA AI CO.,LTD.MNI2016-10-28
088000333847794CIS VANE SPINE SYSTEMALPHA AI CO.,LTD.MNI2016-10-28
088000333847864CIS VANE SPINE SYSTEMALPHA AI CO.,LTD.MNI2016-10-28
088000333850974CIS VANE SPINE SYSTEMALPHA AI CO.,LTD.MNI2015-12-11