Medtronic Reusable Instruments

Cobb EX0511151 18MM Bayonette Shaft Flat

Registry build 21.09.26
5manufacturers in China registered for this device type
71catalogue 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 Medtronic Reusable Instruments
Listed by Medtronic Sofamor Danek, Inc., United States
FDA product code HTE
Device type Elevator
Device class Class 1
Regulation 21 CFR 878.4800
Premarket notification Exempt
Record published 2022-10-10
Record revised 2023-10-27 (version 2)

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
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Medtronic Reusable Instruments
Catalogue number Size Status
EX0917015 In distribution
EX0511151 In distribution
X0918025 In distribution
EX0411366 In distribution
EX0511072 In distribution
X0804200 In distribution
EX0425012 In distribution
EX2942034 In distribution
EX0510279 In distribution
EX0714088 In distribution
EX0518062 In distribution
EX1017022 In distribution
EX0211134 In distribution
EX0211133 In distribution
X0625007 In distribution
EX0922013 In distribution
X0324047 In distribution
X1217043 In distribution
X0498-005 In distribution
EX1017023 In distribution
EX2942035 In distribution
EX0719017 In distribution
X0395-009 In distribution
X0617012 In distribution
5330025 In distribution
EX0922014 In distribution
EX0510278 In distribution
X0518044 In distribution
EX06131005 In distribution
X0625005 In distribution
X0412087 In distribution
EX0318042 In distribution
EX1210165 In distribution
EX0619005 In distribution
X0518045 In distribution
EX0811383 In distribution
85626 In distribution
EX0911183 In distribution
X0617011 In distribution
X1217046 In distribution
EX0912033 In distribution
84631 In distribution
EX0425013 In distribution
X1119016 In distribution
X0324046 In distribution
X0625006 In distribution
X0395-008 In distribution
EX0518061 In distribution
EX0419042 In distribution
X0324048 In distribution
X0901027 In distribution
EX0519090 In distribution
X0602050 In distribution
EX0911184 In distribution
EX0112100 In distribution
EX0911185 In distribution
EX0719014 In distribution
X0811304 In distribution
X1217045 In distribution
EX0719016 In distribution
X0912034 In distribution
X0518046 In distribution
EX0219052 In distribution
X1119017 In distribution
EX0718046 In distribution
X0395-007 In distribution
X0418041 In distribution
EX0912034 In distribution
EX0112101 In distribution
X1217044 In distribution
EX2942033 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
Elmed Elmed, Inc. 67
Elevator Depuy Spine, Inc. 56

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