PMC SMART Solutions, LLC

FDA Device Registration & Listing · Shelbyville, IN, US · Registration 3010408671

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
3010408671
FEI Number
3010408671
Entity Name
PMC SMART Solutions, LLC
City/State/Country
Shelbyville, IN, US
Establishment Address
1451 S. Miller Avenue, Shelbyville, IN 46176, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
PMC SMART Solutions (Owner Number: 10044542)
Owner / Operator Contact Address
1451 S. Miller Avenue, Shelbyville, IN 46176, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Sonopet Disposable Tubing Set and Extender Filter Tubing Eikon LT 40mm, Narrow Eikon LT 135mm, Sweetheart Eikon LT, 175mm CleverLock Guidewire Locking Device and Biopsy Cap GemZipclip PhotonGuide Illuminator, Narrow/ Flat PhotonGuide Illuminator, Wide/ Flat Sonatherm MEDTRONIC CLIP GUN 45805 STRATA II ADJUSTMENT KIT 45805 Strata II Adjustment Tool Hugo™ Robotically Assisted Surgery (RAS) System 4.5mm RTD Twist Drill Vizadisc Carpal Tunnel Release Instruments MEDTRONIC CLIP GUN

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2020-02-11
GAD Retractor General, Plastic Surgery Class 1 878.4800 2021-04-15
ODC Endoscope Channel Accessory Gastroenterology, Urology Class 2 876.1500 2019-04-09
FZP Clip, Implantable General, Plastic Surgery Class 2 878.4300 2025-02-18
FSZ Light, Surgical, Carrier General, Plastic Surgery Class 2 878.4580 2026-05-28
NTB System, Ablation, Ultrasound And Accessories General, Plastic Surgery Class 2 878.4400 2013-07-25
HBO Clip, Scalp Neurology Class 2 882.4150 2016-08-04
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2018-05-18
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2018-05-31
SCV Modular Electromechanical Surgical System General, Plastic Surgery Class 2 878.4964 2026-01-05
HTW Bit, Drill Orthopedic Class 1 888.4540 2020-11-30
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2013-06-25
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2020-11-30
HBO Clip, Scalp Neurology Class 2 882.4150 2016-08-04

Official Correspondent

Jeffrey Burris

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PMC SMART Solutions
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
K922626 Andronic Devices, Ltd. ADEPT INSTRUMENT POSITIONING ACCESSORY 1992-10-19
K820290 The Anspach Effort, Inc. SELF RETAINING RETRACTOR FOR HAND SURG 1982-03-05
K760422 Cutter Laboratories, Inc. SURGICAL RETRACTOR 1976-08-23
K981246 Integra Neurocare, LLC BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850-9720) VALVE KIT (NL850-9730) 1999-05-26
K260601 Blue Belt Technologies, Inc. REAL INTELLIGENCE™ CORI™ 2026-03-26

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0332-2022 Covidien Llc U
Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information on the battery charging progress and battery pack status Item Code: CBCA
Z-0031-2014 Aesculap, Inc. 1
UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
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

Similar Registrations

Registration Number Establishment Name Location
1047843 ISOMEDIX OPERATIONS INC. SPARTANBURG, SC, US
3016245399 NPA de Mexico S.de R.L. de C.V. Tijuana Baja California, MX
3040335671 Stryker Ireland Ltd. Instruments Division, Innovation Centre Carrigtwohill Cork (County), IE
3009941480 LISI MEDICAL REmmele Big Lake, MN, US
1724474 Terumo BCT STERILIZATION SERVICES, Inc. LAKEWOOD, CO, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010408671. Last updated year: 2026. Please use registration number 3010408671 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.