FDA.reportPublic FDA data

Libra Pedicle Screw System

Primary DI
00841327102745
Brand
Libra Pedicle Screw System
Company
SPINAL BALANCE, INC.
Model
LP4525
Device description
Libra Screw Assembly, Polyaxial, 4.5mm x 25mm
Published
2016-05-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation
NKBOrthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151770000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151770000Libra Pedicle Screw SystemSpinal Balance, Inc.2015-11-20NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841327102745PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841327102745008413271027458413271027450841327102745

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, sterileAn assembly of 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. Sterile disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length25Millimeter
Outer Diameter4.5Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
419-530-5940customerservice@spinalbalance.us

Regulatory Flags#

DUNS number
042418840
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841327102752Libra Pedicle Screw SystemLP45302016-05-27
00841327102769Libra Pedicle Screw SystemLP45352016-05-27
00841327102776Libra Pedicle Screw SystemLP45402016-05-27
00841327102783Libra Pedicle Screw SystemLP45452016-05-27
00841327102790Libra Pedicle Screw SystemLP45502016-05-27
00841327103124Libra Pedicle Screw SystemLP55302016-05-27
00841327103131Libra Pedicle Screw SystemLP5530C2016-05-27
00841327103148Libra Pedicle Screw SystemLP55352016-05-27
00841327103155Libra Pedicle Screw SystemLP5535C2016-05-27
00841327103162Libra Pedicle Screw SystemLP55402016-05-27
00841327103179Libra Pedicle Screw SystemLP5540C2016-05-27
00841327103186Libra Pedicle Screw SystemLP55452016-05-27
00841327103193Libra Pedicle Screw SystemLP5545C2016-05-27
00841327103209Libra Pedicle Screw SystemLP55502016-05-27
00841327103216Libra Pedicle Screw SystemLP5550C2016-05-27
00841327103223Libra Pedicle Screw SystemLP55552016-05-27
00841327103230Libra Pedicle Screw SystemLP5555C2016-05-27
00841327103247Libra Pedicle Screw SystemLP55602016-05-27
00841327103254Libra Pedicle Screw SystemLP5560C2016-05-27
00841327103780Libra Pedicle Screw SystemLP65252016-05-27

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