FDA.reportPublic FDA data

Liberty Anterior Cervical Plate

Primary DI
00811771030086
Brand
Liberty Anterior Cervical Plate
Company
VALORUS SPINE LLC
Model
20-01-0126
Device description
Cervical Plate, 1-level, 26mm
Published
2023-07-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172585000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172585000Liberty Anterior Cervical PlateValorus Spine2017-10-23KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811771030086PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811771030086008117710300868117710300860811771030086

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA small implantable sheet of solid material that is attached to the spine with screws for spinal immobilization and is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
760-799-4353lfero@valorusspine.com

Regulatory Flags#

DUNS number
080841846
Device count
1
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811771030000Liberty Anterior Cervical Plate20-01-01102023-07-14
00811771030017Liberty Anterior Cervical Plate20-01-01122023-07-14
00811771030024Liberty Anterior Cervical Plate20-01-01142023-07-14
00811771030031Liberty Anterior Cervical Plate20-01-01162023-07-14
00811771030048Liberty Anterior Cervical Plate20-01-01182023-07-14
00811771030055Liberty Anterior Cervical Plate20-01-01202023-07-14
00811771030062Liberty Anterior Cervical Plate20-01-01222023-07-14
00811771030079Liberty Anterior Cervical Plate20-01-01242023-07-14
00811771030093Liberty Anterior Cervical Plate20-01-02242023-07-14
00811771030109Liberty Anterior Cervical Plate20-01-02262023-07-14
00811771030116Liberty Anterior Cervical Plate20-01-02282023-07-14
00811771030123Liberty Anterior Cervical Plate20-01-02302023-07-14
00811771030130Liberty Anterior Cervical Plate20-01-02322023-07-14
00811771030147Liberty Anterior Cervical Plate20-01-02342023-07-14
00811771030154Liberty Anterior Cervical Plate20-01-02372023-07-14
00811771030161Liberty Anterior Cervical Plate20-01-02402023-07-14
00811771030178Liberty Anterior Cervical Plate20-01-02432023-07-14
00811771030185Liberty Anterior Cervical Plate20-01-02462023-07-14
00811771030192Liberty Anterior Cervical Plate20-01-03392023-07-14
00811771030208Liberty Anterior Cervical Plate20-01-03422023-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840466901035PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901042PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901059PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901066PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901073PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901080PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901097PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901103PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901110PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901127PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901141PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901158PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901165PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901172PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901479PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901486PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901493PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901509PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901516PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901523PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901530PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901547PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901554PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901561PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901578PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901585PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901592PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901608PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901615PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901622PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21