Libra Pedicle Screw System

GUDID 00841327105364

Libra Screw Assembly, Polyaxial, 8.5mm x 80mm

SPINAL BALANCE, INC.

Bone-screw internal spinal fixation system, sterile
Primary Device ID00841327105364
NIH Device Record Key18a1128d-766d-4cb7-b207-61dbc7f5ba75
Commercial Distribution StatusIn Commercial Distribution
Brand NameLibra Pedicle Screw System
Version Model NumberLP8580
Company DUNS042418840
Company NameSPINAL BALANCE, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone419-530-5940
Emailcustomerservice@spinalbalance.us
Phone419-530-5940
Emailcustomerservice@spinalbalance.us
Phone419-530-5940
Emailcustomerservice@spinalbalance.us
Phone419-530-5940
Emailcustomerservice@spinalbalance.us
Phone419-530-5940
Emailcustomerservice@spinalbalance.us
Phone419-530-5940
Emailcustomerservice@spinalbalance.us
Phone419-530-5940
Emailcustomerservice@spinalbalance.us

Device Dimensions

Length50 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100841327105364 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNHOrthosis, Spondylolisthesis Spinal Fixation

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-11-10

On-Brand Devices [Libra Pedicle Screw System]

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00841327107658Libra Rod, Straight, CoCr 400mm Steam Sterilized
00841327107627Libra Rod, Straight, 300mm
00841327107610Libra Rod, Straight, CoCr 300mm
00841327107290Libra Rod, Straight, Threaded, CoCr 600mm
00841327107078Libra Rod, Straight, CoCr 400mm
008413271065697.0mm Screw Tap
00841327106262Libra Set Screw
00841327106194Libra rod, pre-bent, 90mm
00841327106187Libra Rod, Straight, 90mm
00841327106118Libra rod, Pre-bent, 80mm
00841327106101Libra Rod, Straight, 80mm
00841327106033Libra rod, Pre-bent, 70mm
00841327106026Libra Rod, Straight, 70mm
00841327105999Libra Rod, Pre-Bent, 65mm
00841327105968Libra Rod, Straight, 600mm
00841327105937Libra Rod, Pre-bent, 60mm
00841327105920Libra Rod, Straight, 60mm
00841327105890Libra Rod, Pre-Bent, 55mm
00841327105838Libra Rod, Pre-bent, 50mm
00841327105821Libra Rod, Straight, 50mm
00841327105791Libra Rod, Pre-bent, 45mm
00841327105760Libra Rod, Straight, 400mm
00841327105739Libra Rod, Pre-bent, 40mm
00841327105722Libra Rod, Straight, 40mm
00841327105692Libra Rod, Pre-bent, 35mm
00841327105685Libra Rod, Straight, 35mm
00841327105661Libra Rod, Straight, 200mm
00841327105647Libra Rod, Straight, 150mm
00841327105616Libra Rod, Pre-bent, 120mm
00841327105609Libra Rod, Straight, 120mm
00841327105579Libra Rod, Pre-bent, 115mm
00841327105531Libra Rod, Pre-bent, 110mm
00841327105524Libra Rod, Straight, 110mm
00841327105456Libra Rod, Pre-Bent, 100mm
00841327105449Libra Rod, Straight, 100mm
00841327105418Libra Screw Assembly, Polyaxial, cannulated, 8.5mm x 90mm
00841327105401Libra Screw Assembly, Polyaxial, 8.5mm x 90mm
00841327105371Libra Screw Assembly, Polyaxial, cannulated, 8.5mm x 80mm
00841327105364Libra Screw Assembly, Polyaxial, 8.5mm x 80mm
00841327105111Libra Screw Assembly, Polyaxial, cannulated, 8.5mm x 100mm
00841327105104Libra Screw Assembly, Polyaxial, 8.5mm x 100mm
00841327104619Libra Screw Assembly, Polyaxial, Cannulated, 7.5mm x 60mm
00841327104602Libra Screw Assembly, Polyaxial, 7.5mm x 60mm
00841327104596Libra Screw Assembly, Polyaxial, Cannulated, 7.5mm x 55mm
00841327104589Libra Screw Assembly, Polyaxial, 7.5mm x 55mm
00841327104572Libra Screw Assembly, Polyaxial, Cannulated, 7.5mm x 50mm
00841327104565Libra Screw Assembly, Polyaxial, 7.5mm x 50mm
00841327104558Libra Screw Assembly, Polyaxial, Cannulated, 7.5mm x 45mm
00841327104541Libra Screw Assembly, Polyaxial, 7.5mm x 45mm
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