Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027614879

FEI Number

3027614879

Entity Name

Betts Precision

City/State/Country

Alsip, IL, US

Establishment Address

4857 W 115TH St, Alsip, IL 60803, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Betts Precision (Owner Number: 10077640)

Owner / Operator Contact Address

4857 W. 115th Street, Alsip, IL 60803, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Funnel, 5.8mm Outer Diameter ALIF Distractor, 37mm Annulus Steerable Guide Sleeve, Small Implant ALIF Retractor, 220mm Hohmann Spiked Start Sleeve, Cannulated ALIF Retractor, 200mm Hohmann ALIF Retractor, 180mm Hohmann Reline-O Needle Guide, Fenestrated Reline Needle Guide, Fenestrated Tip ALIF Paddle Distractor,10mm Ang Top Thin Soft Tissue Sleeve Drill Sleeve Reline MAS Needle Guide, Fenestrated ALIF Distractor, 42mm Annulus Shank Removal Driver - Standard Length 8.8" Graft Pusher, 5.8mm Outer Diameter ALIF Distractor, 33mm Annulus ALIF Retractor, Hohmann Hook ALIF Distractor, 40mm Annulus Reline MAS SS Dilator, Large Tap Reline MAS Tap Dilator, SS Red Screw Reline MAS Dilator, Screw Metal Reline MAS Dilator, Tap Metal Reline MAS Dilator, Initial Metal Reline MAS Dilator, SS Red Screw Square Drive shaft, Removal Tool Square Drive Coupler, Removal Tool Cannulated Alignment Tool

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2023-07-17
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2023-07-20
HWB	Extractor	Orthopedic	Class 1	888.4540	2023-07-17

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Betts Precision

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
K833646	Edward Weck, Inc.	PULSATRON NERVE LOCATOR/STIMULATOR	1984-02-10
K150005	Ndi Medical, LLC	Checkpoint, Checkpoint Head & Neck	2015-02-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

Similar Registrations

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3021574846	3D LOGICS LLC	Hillsboro, OR, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027614879. Last updated year: 2026. Please use registration number 3027614879 when referencing this establishment in official correspondence.