Orthomed

Mayo Hegar N.H. 6" Serr Carb. Left Handed

Registry build 21.09.26
15manufacturers in China registered for this device type
134catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (5), Zhejiang (3), Shanghai (2). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code HXK
Manufacturer City Province Registered as Device types
B-ONE Medical (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai Shanghai Exporter 106
GRI Medical & Electronic Technology Co., Ltd. Jiaxing Zhejiang Contract manufacturer 71
Anhui Medpurest Medical Technology Co., Ltd. Anqing Anhui Manufacturer 46
Anqing Kangmingna Packaging Co., Ltd. Anqing Anhui Contract manufacturer 39
Beijing Fule Science & Technology Development Co., Ltd. Beijing Beijing Manufacturer 31
Suzhou Microport Orthorecon Co., Ltd. Suzhou Jiangsu Contract manufacturer 31
Shanghai Reach Medical Instrument Co., Ltd. Shanghai Shanghai Manufacturer 30
Ningbo Yingmed Medical Instruments Co., Ltd. Ningbo Zhejiang Manufacturer 29
Asol Co., Ltd. Huaian Jiangsu Manufacturer 22
Huaian Tisurg Medical Instruments Co., Ltd. Huaian Jiangsu Contract manufacturer 22

Showing 12 of 15. All 15 manufacturers in China registered for Holder, Needle; Orthopedic

Record

Regulatory record for Orthomed
Listed by Ortho-MED, Inc., United States
FDA product code HXK
Device type Holder, Needle; Orthopedic
Device class Class 1
Regulation 21 CFR 888.4540
Establishment Repacker / relabeller
Premarket notification Exempt
Record published 2022-07-19
Record revised 2024-04-10 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization

Catalogue Numbers

Catalogue numbers for Orthomed
Catalogue number Size Status
OM 41-0265 In distribution
OM 44-0160 In distribution
OM 41-0065 In distribution
OM 44-0133 In distribution
OM 44-0153 In distribution
OM 44-0172 In distribution
OM 41-0162 In distribution
OM 41-0267 In distribution
OM 44-0217 In distribution
OM 44-0168 In distribution
OM 41-0248 In distribution
OM 41-0257 In distribution
OM 42-0185 In distribution
OM 44-0123 In distribution
OM 41-0200 In distribution
OM 42-0132 In distribution
OM 44-0129 In distribution
OM 41-0268 In distribution
OM 44-0207 In distribution
OM 44-0152 In distribution
OM 44-0131 In distribution
OM 42-0195 In distribution
OM 44-0127 In distribution
OM 44-0213 In distribution
OM 44-0176 In distribution
OM 44-0124 In distribution
OM 41-0070 In distribution
OM 42-0134 In distribution
OM 41-0067 In distribution
OM 44-0122 In distribution
OM 41-0244 In distribution
OM 41-0166 In distribution
OM 41-0302L In distribution
OM 44-0218 In distribution
OM 41-0316 In distribution
OM 44-0177 In distribution
OM 44-0220 In distribution
OM 41-0064 In distribution
OM 44-0150 In distribution
OM 44-0137 In distribution
OM 44-0155 In distribution
OM 41-0278 In distribution
OM 44-0126 In distribution
OM 44-0170 In distribution
OM 44-0121 In distribution
OM 44-0163 In distribution
OM 44-0221 In distribution
OM 42-0197 In distribution
OM 41-0094 In distribution
OM 44-0219 In distribution
OM 41-0174 In distribution
OM 44-0136 In distribution
OM 44-0216 In distribution
OM 44-0169 In distribution
OM 42-0191 In distribution
OM 41-0104 In distribution
OM 41-0242 In distribution
OM 44-0162 In distribution
OM 44-0212 In distribution
OM 41-0314 In distribution
OM 41-0132 In distribution
OM 42-0190 In distribution
OM 44-0206 In distribution
OM 44-0132 In distribution
OM 44-0214 In distribution
OM 41-0171 In distribution
OM 44-0210 In distribution
OM 44-0215 In distribution
OM 44-0032 In distribution
OM 41-0172 In distribution
OM 41-0108 In distribution
OM 42-0188 In distribution
OM 44-0166 In distribution
OM 44-0175 In distribution
OM 44-0222 In distribution
OM 44-0211 In distribution
OM 42-0187 In distribution
OM 41-0164 In distribution
OM 41-0176 In distribution
OM 44-0171 In distribution
OM 44-0209 In distribution
OM 44-0125 In distribution
OM 44-0165 In distribution
OM 44-0157 In distribution
OM 41-0300 In distribution
OM 44-0205 In distribution
OM 44-0135 In distribution
OM 41-0284 In distribution
OM 42-0186 In distribution
OM 44-0139 In distribution
OM 41-0173 In distribution
OM 44-0204 In distribution
OM 44-0167 In distribution
OM 44-0203 In distribution
OM 41-0272 In distribution
OM 44-0154 In distribution
OM 42-0192 In distribution
OM 41-0066 In distribution
OM 44-0173 In distribution
OM 42-0196 In distribution
OM 41-0246 In distribution
OM 41-0302 In distribution
OM 41-0270 In distribution
OM 41-0286 In distribution
OM 41-0170 In distribution
OM 41-0130 In distribution
OM 41-0266 In distribution
OM 41-0308 In distribution
OM 42-0198 In distribution
OM 44-0164 In distribution
OM 41-0264 In distribution
OM 44-0200 In distribution
OM 41-0106 In distribution
OM 44-0156 In distribution
OM 41-0092 In distribution
OM 44-0134 In distribution
OM 44-0161 In distribution
OM 44-0174 In distribution
OM 41-0198 In distribution
OM 44-0202 In distribution
OM 41-0240 In distribution
OM 44-0159 In distribution
OM 44-0201 In distribution
OM 42-0189 In distribution
OM 44-0178 In distribution
OM 41-0068 In distribution
OM 44-0128 In distribution
OM 41-0175 In distribution
OM 44-0138 In distribution
OM 44-0158 In distribution
OM 44-0208 In distribution
OM 44-0130 In distribution
OM 44-0223 In distribution
OM 44-0151 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Sklar® Sklar Corporation 675
Needle Holder KLS-Martin L.P. 183
Anmuth Medical International Anmuth Medical International LLC 148
gSource Gsource, LLC. 147
BMT Medizintechnik GmbH BMT Medizintechnik GmbH 139
Holder, Needle; Orthopedic Fehling Instruments GmbH 119
Marina Medical Marina Medical Instruments, Inc. 115
Durogrip Aesculap AG 78
Stephens Instruments Krishna Imports Inc 77
Aesculap Aesculap AG 73
Diadust Aesculap AG 71
Zoll-Dental Zoll-Dental 64

Showing 12 of 158. All products under Holder, Needle; Orthopedic

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