REVELATION MEDICAL DEVICES, LLC

FDA Device Registration & Listing · Auburn, IN, US · Registration 1836116

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
1836116
FEI Number
3002687954
Entity Name
REVELATION MEDICAL DEVICES, LLC
City/State/Country
Auburn, IN, US
Establishment Address
1105 West Auburn Street, Auburn, IN 46706, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer),Remanufacture Medical Device,Manufacture Medical Device
Owner / Operator
REVELATION MEDICAL DEVICES LLC (Owner Number: 10051413)
Owner / Operator Contact Address
1105 WEST AUBURN DRIVE, Auburn, IN 46706, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Shoulder Innovations Total Shoulder System Shoulder Innovations Total Shoulder Replacement System Shoulder Innovations Total Shoulder Replacement System INTEGRATE-C Interbody Fusion System Recon RMD Inset Reverse Total Shoulder System Shoulder Innovations Total Shoulder Replacement System RMD Recon

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2023-09-19
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2023-09-19
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2023-09-19
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2023-09-19
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2023-09-19
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2023-09-19
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2023-09-19
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2023-09-19
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2023-08-01
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2016-03-15
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2023-09-19
MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3670 2023-09-19
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2023-09-19
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2023-09-19
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2023-09-19
GAD Retractor General, Plastic Surgery Class 1 878.4800 2024-12-19

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

REVELATION MEDICAL DEVICES 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
K904879 Endotec, Inc. BEUCHEL-PAPPAS GLENOID COMPONENT 1991-01-28
K984202 Howmedica, Inc. HOWMEDICA HUMERAL INTERCALARY SYSTEM 1999-02-05
K142269 Reliance Medical Systems, LLC Reliance Cervical IBF System 2015-06-09
K122085 Omni Surgical, LP Dba Spine360 STINGRAY CERVICAL CAGE 2012-10-17
K120275 Synthes (Usa), LLC SYNTHES ACIS/VERTEBRAL SPACER CR 2012-05-25

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0023-06 Zimmer Inc. 2
Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604000.
Z-0024-06 Zimmer Inc. 2
Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604046.
Z-0025-06 Zimmer Inc. 2
Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604640.
Z-0026-06 Zimmer Inc. 2
Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604600.
Z-0027-06 Zimmer Inc. 2
Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 52 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604652.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1836116. Last updated year: 2026. Please use registration number 1836116 when referencing this establishment in official correspondence.
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