Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011685188

FEI Number

3011685188

Entity Name

Zentech Inc.

City/State/Country

Clearwater, FL, US

Establishment Address

611 Druid Rd E. Ste 200, Clearwater, FL 33756, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Zentech Inc. (Owner Number: 10049480)

Owner / Operator Contact Address

611 Druid Rd E., Ste 200, Clearwater, FL 33756, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTO	Reamer	Orthopedic	Class 1	888.4540	2015-06-05
GFG	Bit, Surgical	General, Plastic Surgery	Class 1	878.4820	2015-06-05
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2015-06-05

Official Correspondent

Courtney Chambless

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Zentech Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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 3011685188. Last updated year: 2026. Please use registration number 3011685188 when referencing this establishment in official correspondence.