PALAXA PRECISION LLC

FDA Device Registration & Listing · Newport, MN, US · Registration 3043841530

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
3043841530
FEI Number
3043841530
Entity Name
PALAXA PRECISION LLC
City/State/Country
Newport, MN, US
Establishment Address
2104 Hastings Ave Ste 270, Newport, MN 55055, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Palaxa Precision LLC (Owner Number: 10094830)
Owner / Operator Contact Address
2104 Hastings Ave., Suite 270, Newport, MN 55055, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K202691
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DYJ Retainer, Screw Expansion, Orthodontic Dental Class 1 872.5410 2026-03-10
OAT Implant, Endosseous, Orthodontic Dental Class 2 872.3640 2026-03-10

Official Correspondent

Charles Kaufman

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Palaxa Precision LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K110392 Psm Medical Solutions PSM LOMAS / BENEFIT SCREWS 2011-12-14

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3024749697 SPRINTRAY INC. Huntington Beach, CA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043841530. Last updated year: 2026. Please use registration number 3043841530 when referencing this establishment in official correspondence.
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