RMR ORTHO, Inc

FDA Device Registration & Listing · San Antonio, TX, US · Registration 3031160399

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
3031160399
FEI Number
3031160399
Entity Name
RMR ORTHO, Inc
City/State/Country
San Antonio, TX, US
Establishment Address
4600 Lockhill Selma Road Suite 107, San Antonio, TX 78249, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
RMR Ortho, LLC (Owner Number: 10090810)
Owner / Operator Contact Address
4600 Lockhill Selma Road Suite 107, San Antonio, TX 78249, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K231458
PMA Number
N/A

All Registered Proprietary Names

A’TOMIC™ Nitinol Fixation System A'TOMIC PULSE

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2024-05-16
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2025-08-19

Official Correspondent

Monica Lesch

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

RMR Ortho, 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
K153770 In2bones Sas OS2(R)-VP Varisation Staple 2016-03-21

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0008-2023 Synthes (USA) Products LLC 2
Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031160399. Last updated year: 2026. Please use registration number 3031160399 when referencing this establishment in official correspondence.
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