Medtronic Reusable Instruments

Micropituitary X0810866 2MM Serrated LNG

Registry build 21.09.26
11manufacturers in China registered for this device type
80catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (5), Shandong (3), Jiangsu (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HTX
Manufacturer City Province Registered as Device types
B.Braun Medical (Suzhou) Co,.Ltd Suzhou Jiangsu Contract manufacturer 37
Xinhua Healthcare Industry Co., Limited Zibo Shandong Contract manufacturer 30
Shanghai KiNETIC Medical Co Ltd Shanghai Shanghai Contract manufacturer 19
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai Shanghai Exporter 106
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82
Shanghai Kangqiao Dental Instruments Factory Shanghai Shanghai Manufacturer 54
Beijing Fule Science & Technology Development Co., Ltd. Beijing Beijing Manufacturer 31
Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. Changzhou Jiangsu Contract manufacturer 25
Qingdao Zhixing Medical Instrument Co., Ltd. Qingdao Shandong Manufacturer 6

Record

Regulatory record for Medtronic Reusable Instruments
Listed by Medtronic Sofamor Danek, Inc., United States
FDA product code HTX
Device type Rongeur
Device class Class 1
Regulation 21 CFR 888.4540
Premarket notification Exempt
Record published 2022-11-27
Record revised 2025-11-13 (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
Distribution end date 2025-11-11
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Medtronic Reusable Instruments
Catalogue number Size Status
X0512061 In distribution
X1105022 In distribution
X1225015 In distribution
X1225003 In distribution
X1225012 In distribution
X0505107 In distribution
X1103008 In distribution
X0303008 In distribution
X0300024 In distribution
X0505109 In distribution
X0810866 In distribution
X1225010 In distribution
EX1211058 In distribution
907610 In distribution
X0397-022 In distribution
X0810868 In distribution
X0605160 In distribution
X9560536 In distribution
EX0219034 In distribution
X0397-021 In distribution
X1225008 In distribution
X0512064 In distribution
3280002 In distribution
X1101566 In distribution
EX0312682 In distribution
X1097-076 In distribution
EX0511013 In distribution
X0497-010 In distribution
EX1010071 In distribution
X0603018 In distribution
EX0710356 In distribution
X1225006 In distribution
X1119018 In distribution
EX0711017 In distribution
X1225002 In distribution
X1225014 In distribution
X0300023 In distribution
X1225009 In distribution
EX1211059 In distribution
X0397-023 In distribution
X9560565 In distribution
X0497-011 In distribution
X1096-032 In distribution
X1225004 In distribution
907-409 In distribution
EX1225003 In distribution
X1001567 In distribution
950-945 In distribution
950-972 In distribution
EX0312683 In distribution
EX0219033 In distribution
X1225005 In distribution
950-941 In distribution
X1225011 In distribution
950-947 In distribution
X1000005 In distribution
950-940 In distribution
X0512062 In distribution
EX1110216 In distribution
X0505108 In distribution
EX0711018 In distribution
9116882 In distribution
EX1125006 In distribution
X1225007 In distribution
X9560570 In distribution
X0512063 In distribution
X0301001 In distribution
EX1010072 In distribution
X1225013 In distribution
X9560564 Withdrawn
YIB1201-015 Withdrawn
X0102005 Withdrawn
YIB1001-013 Withdrawn
X9560569 Withdrawn
X0309259 Withdrawn
X1110216 Withdrawn
X1111002 Withdrawn
YIB0801-046 Withdrawn
X9560567 Withdrawn
YIB1001-012 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Sklar® Sklar Corporation 2,994
Life Instruments Life Instrument Corp. 1,252
Novo Surgical Novo Surgical, Inc. 1,227
Surgical Direct Surgical Direct, Inc. 1,208
Medicon Medicon eG. Chirurgiemechaniker-Genossenschaft 712
gSource Gsource, LLC. 509
Novo Surgical Inc. Novo Surgical, Inc. 397
Peak MED Peak Medical Distribution Inc 320
Aesculap Aesculap AG 264
MSI Precision Specialty Instruments MED Saver, Inc. 244
Integra® Ruggles®-Redmond™ Integra LifeSciences Production Corporation 239
HNM Medical HNM Stainless, LLC. 186

Showing 12 of 438. All products under Rongeur

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