FDA.reportPublic FDA data

Patriot Spinal Fixation System

Primary DI
00811771032561
Brand
Patriot Spinal Fixation System
Company
VALORUS SPINE LLC
Model
10-99-0001
Device description
Awl
Published
2023-07-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180324000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180324000Patriot Spinal Fixation SystemValorus Spine2018-04-06NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811771032561PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811771032561008117710325618117710325610811771032561

GMDN Terms#

Term, Definition table
TermDefinition
Bone awl, reusableA spike-like, manual, orthopaedic surgical instrument intended to bore holes in bone. It is a straight or slightly curve rod-like instrument with a sharp, trocar-like point at the distal end and a T-shaped handle at the proximal end, typically made of metallic and/or synthetic material. This is a reusable device.

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
00811771030086Liberty Anterior Cervical Plate20-01-01262023-07-14
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995323592V. MuellerSTERIS Deutschland GmbHLXH2026-09-25
00840606186223ALIF Disc PrepSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186230ALIF Disc PrepSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186261ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186278ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186285ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606187381ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00843193112699Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
00843193112705Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
07630040795166Surgical Manual InstrumentMedacta International SALXH2026-09-25
07630542792359Surgical Manual InstrumentMedacta International SALXH2026-09-25
20845854655501Argo KnotlessConmed CorporationLXH2026-09-25
20845854655518Argo KnotlessConmed CorporationLXH2026-09-25
00810130207541MSIModern Surgical Instruments LLCLXH2026-09-24
00810130207558MSIModern Surgical Instruments LLCLXH2026-09-24
00840606185929PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606185936PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186773PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186780PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187237PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187244PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187251PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00885556854778Cadence Total Ankle SystemSmith & Nephew, Inc.LXH2026-09-24
07899258601670Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-09-24
B7685215250Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2026-06-19
B7683434130Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2026-04-23
B7685216220Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-13
B7685111560Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B768521135180Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B7685216060Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03