Integra® Miltex®

Integra® Miltex® Sayre Periosteal Elevator 6-3/4", Double-Ended, Sharp Curved Blade and Blunt Straight Blade

Registry build 21.09.26
5manufacturers in China registered for this device type
31catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (2), Jiangsu (2), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code HTE
Manufacturer City Province Registered as Device types
Paragon Medical Device (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 53
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82
Huaian Tisurg Medical Instruments Co., Ltd. Huaian Jiangsu Contract manufacturer 22

Record

Regulatory record for Integra® Miltex®
Listed by Integra LifeSciences Production Corporation, United States
FDA product code HTE
Device type Elevator
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Contract manufacturer, Specification developer, Manufacturer
Premarket notification Exempt
Record published 2018-01-12
Record revised 2024-10-11 (version 9)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries lot or batch number
Sizes Width 5 mm; length 7 in

Catalogue Numbers

Catalogue numbers for Integra® Miltex®
Catalogue number Size Status
27-2040 In distribution
26-1403 In distribution
27-822 In distribution
27-2020 In distribution
26-1432 In distribution
27-826 In distribution
27-748 In distribution
26-1412 In distribution
27-821 In distribution
27-2010 In distribution
26-1436 In distribution
MH18-1968 Width 5 mm In distribution
26-1430 In distribution
27-752 In distribution
27-744 In distribution
27-824 In distribution
26-1434 In distribution
27-820 In distribution
27-750 In distribution
27-753 In distribution
27-746 In distribution
27-754 In distribution
40-69 In distribution
27-749 In distribution
18-1968 Width 5 mm In distribution
40-96 In distribution
40-94 In distribution
27-747 In distribution
27-2001 In distribution
26-1410 In distribution
27-2030 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Life Instruments Life Instrument Corp. 383
General Instruments Alphatec Spine, Inc. 326
Timberline Lateral Fusion System Highridge Medical, LLC 209
Battalion Alphatec Spine, Inc. 152
IdentiTi Alphatec Spine, Inc. 110
Intervertebral Disc Preparation Instruments Alphatec Spine, Inc. 103
Orthomed Ortho-MED, Inc. 100
Tecomet Tecomet, Inc. 88
Innomed, Inc. Innomed, Inc. 85
General Instrument Alphatec Spine, Inc. 85
Medtronic Reusable Instruments Medtronic Sofamor Danek, Inc. 71
Elmed Elmed, Inc. 67

Showing 12 of 246. All products under Elevator

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer