FDA.reportPublic FDA data

Valence Robotic Navigation System

Primary DI
00190376688879
Brand
Valence Robotic Navigation System
Company
ALPHATEC SPINE, INC.
Model
268-01-000-08-VN
Device description
OSTEOTOME, POST NAV, 8MM
Published
2026-02-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLOOrthopedic stereotaxic instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252597000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252597000Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)Alphatec Spine, Inc.2026-02-19OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190376688879PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190376688879001903766888791903766888790190376688879

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic osteotomeA chisel-like, one-piece manual surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design, and is typically bevelled on both sides with sloping curves. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(760)431-9286Regulatory@alphatecspine.com

Regulatory Flags#

DUNS number
602465783
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190376541471ATEC Lateral Navigation Disc Prep Instruments267-01-000-10-N2024-12-18
00190376529158ATEC Posterior Navigation Disc Prep Instruments244-01-000-06-N2024-04-20
00190376529189ATEC Posterior Navigation Disc Prep Instruments244-01-000-12-N2024-04-20
00190376476162ATEC Lateral Navigation Disc Prep Instruments266-01-000-08-N2023-08-26
00190376476179ATEC Lateral Navigation Disc Prep Instruments266-01-000-10-N2023-08-26
00190376476186ATEC Lateral Navigation Disc Prep Instruments266-01-000-12-N2023-08-26
00190376522906ATEC Lateral Navigation Disc Prep Instruments266-01-000-14-N2023-08-26
00840180512395General InstrumentsCI-11129-34242026-05-15
00840180543214General InstrumentsCI-118992026-05-15
00840180543542General InstrumentsCI-11915-302026-05-15
00840180544785General InstrumentsCI-11939-080-R2026-05-15
00840180544914General InstrumentsCI-11939-080-L2026-05-15
00840180545324General InstrumentsCI-11968-06-S2026-05-15
00840180545331General InstrumentsCI-11968-06-L2026-05-15
00840180545362General InstrumentsCI-11968-S2026-05-15
00840180545416General InstrumentsCI-11972-012026-05-15
00840180545423General InstrumentsCI-11972-032026-05-15
00840180545430General InstrumentsCI-11972-022026-05-15
00840180545447General InstrumentsCI-11972-042026-05-15
00840180545461General InstrumentsCI-11969-L2026-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000914035Stealth AXiSMEDTRONIC NAVIGATION, INC.OLO2026-07-17
00763000914042Stealth AXiSMEDTRONIC NAVIGATION, INC.OLO2026-07-17
00763000914059Stealth AXiSMEDTRONIC NAVIGATION, INC.OLO2026-07-17
00763000914066Stealth AXiSMEDTRONIC NAVIGATION, INC.OLO2026-07-17
00763000914073Stealth AXiSMEDTRONIC NAVIGATION, INC.OLO2026-07-17
00763000914080Stealth AXiSMEDTRONIC NAVIGATION, INC.OLO2026-07-17
00763000953805Stealth AXiSMEDTRONIC NAVIGATION, INC.OLO2026-07-17
18257200140367NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140374NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140381NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140398NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140404NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140411NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140428NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140435NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140442NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140459NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140466NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140473NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140527FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17
18257200140534FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17
18257200140558FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17
18257200140565FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17
18257200140572FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17
18257200140596FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17
18257200140602FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17
18257200140619FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17
18257200140626FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17
18257200140633FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17
18257200140657FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17