TriPoint Surgical

FDA Device Registration & Listing · Columbia City, IN, US · Registration 3009973844

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
3009973844
FEI Number
3009973844
Entity Name
TriPoint Surgical
City/State/Country
Columbia City, IN, US
Establishment Address
201 S Towerview Dr, Columbia City, IN 46725, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
TriPoint Surgical (Owner Number: 10042633)
Owner / Operator Contact Address
201 S.Towerview Drive, Columbia City, IN 46725, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Reamer Tap, Bone Orthopedic Manual Surgical Instrument Comprehensive Shoulder System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HTQ Broach Orthopedic Class 1 888.4540 2012-12-14
HTO Reamer Orthopedic Class 1 888.4540 2016-04-13
LYS Bone Mill Orthopedic Class 1 888.4540 2019-10-11
HWX Tap, Bone Orthopedic Class 1 888.4540 2016-04-13
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2016-04-13
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2020-01-13
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2020-01-13

Official Correspondent

Anthony Lozano

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

TriPoint Surgical
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

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0021-2015 Biomet, Inc. 1
Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.
Z-0009-2007 Smith & Nephew Inc 1
Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007 Smith & Nephew Inc 1
Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06 Stryker Howmedica Osteonics Corp. 1
Allocraft TLIF Bone Inserter.
Z-0011-2007 Smith & Nephew Inc 1
Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009973844. Last updated year: 2026. Please use registration number 3009973844 when referencing this establishment in official correspondence.
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