FDA.reportPublic FDA data

FOR USE WITH LINEUM SYSTEM

Primary DI
00888480479765
Brand
FOR USE WITH LINEUM SYSTEM
Company
BIOMET SPINE LLC
Model
LV00350
Catalog number
LV00350
Published
2020-06-27
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
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNHOrthosis, spondylolisthesis spinal fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888480479765PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888480479765008884804797658884804797650888480479765

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. 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
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

Other Devices From This Company#

Primary DI, Brand, Model table
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290115935615Counter Torque STPREMIA SPINE LTDMNH2026-05-25
00763000887070CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2026-03-16
00763000887155CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2026-03-16
00763000992033MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2026-03-14
00841732108134RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732108141RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732108158RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732108165RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732108172RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732108189RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732108196RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732108202RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732108219RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732108226RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732122529RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732122536RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732131835RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732145085RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732145092RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732117860PICASSO II MIS Spinal SystemCTL Medical CorporationMNH2023-09-07
00841732117877PICASSO II MIS Spinal SystemCTL Medical CorporationMNH2023-09-07
00841732117884PICASSO II MIS Spinal SystemCTL Medical CorporationMNH2023-09-07
00841732117891PICASSO II MIS Spinal SystemCTL Medical CorporationMNH2023-09-07
00841732117907PICASSO II MIS Spinal SystemCTL Medical CorporationMNH2023-09-07
00841732117914PICASSO II MIS Spinal SystemCTL Medical CorporationMNH2023-09-07
00840996188715THUNDERBOLT Minimally Invasive Pedicle Screw SystemsChoice Spine, LPMNH2023-02-03
088000333584424CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNH2018-08-17
00841732118959PICASSO II MIS Spinal SystemCTL Medical CorporationMNH2017-08-08
00841732118966PICASSO II MIS Spinal SystemCTL Medical CorporationMNH2017-08-08
00841732118973PICASSO II MIS Spinal SystemCTL Medical CorporationMNH2017-08-08