FDA.reportPublic FDA data

Valence Robotic Navigation System

Primary DI
00190376635569
Brand
Valence Robotic Navigation System
Company
ALPHATEC SPINE, INC.
Model
525-412
Device description
Valence Cart Assembly
Published
2025-01-22
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
K232413000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232413000Fusion Robotic Navigation SystemAlphatec Spine, Inc.2023-09-08OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190376635569PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190376635569001903766355691903766355690190376635569

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
602465783
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190376658933Valence Robotic Navigation System13010-Q-VN2026-10-29
00190376658940Valence Robotic Navigation System13010-VN2026-10-29
00190376659053Valence Robotic Navigation System13110-Q-VN2026-10-29
00190376729374Invictus Spinal Fixation System13603-01-VN2026-10-29
00190376729435Invictus Spinal Fixation System13613-01-VN2026-10-29
00190376749297Valence Robotic Navigation SystemVALPDP2026-10-29
00190376766140Valence Robotic Navigation SystemVNAVSUP2026-10-29
00190376776941Valence Robotic Navigation SystemV2MNVINN2026-10-29
00190376778358Valence Robotic Navigation SystemV2ONVINN2026-10-29
00190376632919Invictus19869-N2026-10-20
00840967110981AlphaGRAFT1002-1002015-09-24
00840967110998AlphaGRAFT1001-0102015-09-24
00840967111001AlphaGRAFT1001-1002015-09-24
00844856026711AlphaGRAFT1001-0502015-09-24
00844856026728AlphaGRAFT1002-0252015-09-24
00844856026735AlphaGRAFT1002-0502015-09-24
00844856032231Osseofix +213902016-10-28
00190376649474CONTOUR3DAIX761032026-09-25
00190376652313CONTOUR3DAIX761012026-09-25
00190376652320CONTOUR3DAIX761022026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000777418CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-11-01
00763000777517CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-11-01
00763000777524CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-11-01
00763000774165CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-31
00763000774172MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-31
00763000774189MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-31
00763000774196MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-31
00763000774202MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-31
00763000774226MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-31
00763000774240MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-31
00763000774257MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-31
00763000774301MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-31
00763000777692MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-31
00763000777739MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-31
00810180351348360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2026-10-30
00810180351676360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2026-10-30
00810180351683360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2026-10-30
00810180351690360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2026-10-30
00824846012832StealthMEDTRONIC NAVIGATION, INC.OLO2026-10-30
B432360CAS010010360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2026-10-30
B432360CAS010020360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2026-10-30
B432360CAS010030360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2026-10-30
B432360CASSET0023B0360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2026-10-30
B432360CASSET0023C0360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2026-10-30
B432360CASSET0025B0360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2026-10-30
B432360CASSET0025C0360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2026-10-30
00190376658933Valence Robotic Navigation SystemALPHATEC SPINE, INC.OLO2026-10-29
00190376658940Valence Robotic Navigation SystemALPHATEC SPINE, INC.OLO2026-10-29
00190376659053Valence Robotic Navigation SystemALPHATEC SPINE, INC.OLO2026-10-29
00190376729374Invictus Spinal Fixation SystemALPHATEC SPINE, INC.OLO2026-10-29