LEM SURGICAL INC

FDA Device Registration & Listing · Tampa, FL, US · Registration 3039520898

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
3039520898
FEI Number
3039520898
Entity Name
LEM SURGICAL INC
City/State/Country
Tampa, FL, US
Establishment Address
4830 W Kennedy Blvd Ste 130, Tampa, FL 33609, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
LEM Surgical Inc (Owner Number: 10093854)
Owner / Operator Contact Address
4830 W Kennedy Blvd, Suite 130, Tampa, FL 33609, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K243326
PMA Number
N/A

All Registered Proprietary Names

Dynamis Robotic Surgical 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 2025-07-23

Official Correspondent

Christopher Prentice

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

LEM Surgical Inc
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
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3039520898. Last updated year: 2026. Please use registration number 3039520898 when referencing this establishment in official correspondence.
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