ALPHATEC SPINE, INC.

FDA Device Registration & Listing · Louisville, CO, US · Registration 3015537048

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3015537048
FEI Number
3015537048
Entity Name
ALPHATEC SPINE, INC.
City/State/Country
Louisville, CO, US
Establishment Address
168 Centennial Parkway, Unit 170, Louisville, CO 80027, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
ALPHATEC HOLDINGS, INC. (Owner Number: 9072657)
Owner / Operator Contact Address
1950 Camino Vida Roble, Carlsbad, CA 92008, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K223070
PMA Number
N/A

All Registered Proprietary Names

Valence Robotic Navigation System Remi Robotic Navigation System Orthopedic Manual Surgical Instrument Valence Robotic Navigation System Remi Robotic Navigation System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2024-12-05
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2023-05-12
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 1999-07-20
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-02-23
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2023-05-12

Official Correspondent

Brian Beireis

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ALPHATEC HOLDINGS, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
2027467 ALPHATEC SPINE, INC. Carlsbad, CA, US
3019878714 Alphatec Spine, Inc. Memphis, TN, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K260601 Blue Belt Technologies, Inc. REAL INTELLIGENCE™ CORI™ 2026-03-26

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0041-2024 Blue Belt Technologies, Inc 2
Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
Z-0009-2007 Smith & Nephew Inc 1
Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007 Smith & Nephew Inc 1
Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06 Stryker Howmedica Osteonics Corp. 1
Allocraft TLIF Bone Inserter.
Z-0011-2007 Smith & Nephew Inc 1
Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015537048. Last updated year: 2026. Please use registration number 3015537048 when referencing this establishment in official correspondence.
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