Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011461101

FEI Number

3011461101

Entity Name

DOT AMERICA, INC.

City/State/Country

Columbia City, IN, US

Establishment Address

335 Towerview Dr, Columbia City, IN 46725, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

DOT America, Inc. (Owner Number: 10048730)

Owner / Operator Contact Address

335 Towerview Drive, Columbia City, IN 46725, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Simplify® Cervical Artificial Disc DJO Surgical MBH - PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER JWH - Porous Coated Discovery Elbow Apex Knee System, Model KC-230XY, KC- 240XY [No Holes, 2 Holes] EVOLUTION NitrX Medial-Pivot Knee - prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/pol Small Diameter Implant (SDI) 3 Dental Implant HSD - PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED PHX - shoulder prosthesis, reverse configuration Identity Revision Stems

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MJO	Prosthesis, Intervertebral Disc	Unknown	Class 3	N/A	2022-04-11
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2015-10-21
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2017-12-27
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2023-08-11
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2023-08-11
JDC	Prosthesis, Elbow, Constrained, Cemented	Orthopedic	Class 2	888.3150	2022-04-11
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2023-11-10
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2019-06-06
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2022-04-11
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2022-04-11
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2022-04-11
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2022-04-11
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2015-02-19
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2025-08-14

Official Correspondent

Michael Venturini

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DOT America, 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
K211871	Faico Medical, LLC	FAICO Dental Implant System and CAD/CAM Abutments	2021-11-18
K901338	Kirschner Medical Corp.	KIRSCHNER MODULAR TCIV TOTAL KNEE SYSTEM	1990-05-22
K030577	Stelkast Company	PROVEN MODULAR TIBIAL TRAY	2003-03-25
K153310	Total Joint Orthopedics, Inc.	Klassic Knee System	2015-12-17
K102380	Wrightmedicaltechnologyinc	EVOLUTION MP TOTAL KNEE SYSTEM	2011-01-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2018	Implant Direct Sybron Manufacturing, LLC	2	Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
Z-0001-2019	Smith & Nephew, Inc.	2	Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 74021222, 74021223, 74021224, 74021225, 74021226, 74021227, 74021228, 74021229
Z-0002-2019	Smith & Nephew, Inc.	2	JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 74021121, 74021122, 74021123, 74021124, 74021125, 74021126, 74021127, 74021128, 74021129, 74021130, 74021131, 74021132, 74021133, 74021134, 74021135, 74021136, 74021137, 74021138, 74021139, 74021140, 74021141, 74021142, 74021143, 74021144, 74021145, 74021146, 74021147, 74021148, 74021149
Z-0003-2017	Zimmer Biomet, Inc.	2	Vanguard 360 Revision Knee System Knee prostheses
Z-0003-2019	Smith & Nephew, Inc.	2	JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116, 74023117, 74023118, 74023121, 74023122, 74023123, 74023124, 74023125, 74023126, 74023127, 74023128, 74023131, 74023132, 74023133, 74023134, 74023135, 74023136, 74023137, 74023138, 74023141, 74023142, 74023143, 74023144, 74023145, 74023146, 74023147, 74023148, 74023211, 74023212, 74023213, 74023214, 74023215, 74023216, 74023217, 74023218, 74023221, 74023222, 74023223, 74023224, 74023225, 74023226, 74023227, 74023228, 74023231, 74023232, 74023233, 74023234, 74023235, 74023236, 74023237, 74023238, 74023241, 74023242, 74023243, 74023244, 74023245, 74023246, 74023247, 74023248, 74023251, 74023252, 74023253, 74023254, 74023255, 74023256, 74023257, 74023258, 74023261, 74023262, 74023263, 74023264, 74023265, 74023266, 74023267, 74023268, 74023271, 74023272, 74023273, 74023274, 74023275, 74023276, 74023277, 74023278, 74023281, 74023282, 74023283, 74023284, 74023285, 74023286, 74023287, 74023288, 74023311, 74023312, 74023313, 74023314, 74023315, 74023316, 74023317, 74023318, 74023321, 74023322, 74023323, 74023324, 74023325, 74023326, 74023327, 74023328, 74023331, 74023332, 74023333, 74023334, 74023335, 74023336, 74023337, 74023338, 74023341, 74023342, 74023343, 74023344, 74023345, 74023346, 74023347, 74023348, 74023411, 74023412, 74023413, 74023414, 74023415, 74023416, 74023417, 74023418, 74023421, 74023422, 74023423, 74023424, 74023425, 74023426, 74023427, 74023428, 74023431, 74023432, 74023433, 74023434, 74023435, 74023436, 74023437, 74023438, 74023441, 74023442, 74023443, 74023444, 74023445, 74023446, 74023447, 74023448, 74023451, 74023452, 74023453, 74023454, 74023455, 74023456, 74023457, 74023458, 74023461, 74023462, 74023463, 74023464, 74023465, 74023466, 74023467, 74023468, 74023471, 74023472, 74023473, 74023474, 74023475, 74023476, 74023477, 74023478, 74023481, 74023482, 74023483, 74023484, 74023485, 74023486, 74023487, 74023488, 74023648, 74203326

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011461101. Last updated year: 2026. Please use registration number 3011461101 when referencing this establishment in official correspondence.