Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1528668

FEI Number

1000136409

Entity Name

Criterion Tool & Die Inc DBA Criterion Precision Machining

City/State/Country

Brookpark, OH, US

Establishment Address

Criterion Tool & Die Inc Dba Criterion Precision Machining, 5349 W 161st St, Brookpark, OH 44142, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

CRITERION TOOL & DIE INC (Owner Number: 9005596)

Owner / Operator Contact Address

5349 WEST 161ST ST., --, Brook Park, OH 44142, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Orthodepic Manual Surgical Instrument Guide, surgical, instrument

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2017-06-08
HTO	Reamer	Orthopedic	Class 1	888.4540	2017-06-08
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2017-05-15
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2013-01-22
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2017-05-15
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2013-01-22
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2013-01-22
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2013-01-22
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2017-06-08
HTO	Reamer	Orthopedic	Class 1	888.4540	2017-06-08
HTO	Reamer	Orthopedic	Class 1	888.4540	2013-01-22

Official Correspondent

TANYA DISALVO

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CRITERION TOOL & DIE 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
K081051	Spine View, Inc.	SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE	2008-08-07
K820777	The Anspach Effort, Inc.	MINI-MICRO ARTHROSCOPIC SCAPEL	1982-05-12
K223112	Smith & Nephew, Inc.	MAVERICK Mini External Fixation System	2022-12-08
K033476	Howmedica Osteonics Corp.	MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM	2004-01-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-05	Linvatec Corp.	2	Ultra Power Burs, Sterile, Single-Use.
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1528668. Last updated year: 2026. Please use registration number 1528668 when referencing this establishment in official correspondence.