Integra® Jarit®

Integra® Jarit® Kolbel Retractor Set (REF#'s 225-324, 225-328, 225-329, 225-330, 225-332, 225-333, 225-334)

Registry build 21.09.26
53manufacturers in China registered for this device type
186catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (24), Guangdong (7), Zhejiang (6). 29 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code LXH
Manufacturer City Province Registered as Device types
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74
Paragon Medical Device (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 53
Canwell Medical Co., Ltd. Jinhua Zhejiang Contract manufacturer 42
Shandong Weigao Orthopaedic Device Co., Ltd. Weihai Shandong Contract manufacturer 42
B.Braun Medical (Suzhou) Co,.Ltd Suzhou Jiangsu Contract manufacturer 37
Suzhou Elite Precision Machinery Co., Ltd. Kunshan Jiangsu Contract manufacturer 35
Xinhua Healthcare Industry Co., Limited Zibo Shandong Contract manufacturer 30
Guangzhou Aquila Precise Tools Limited Guangzhou Guangdong Contract manufacturer 28
B-ONE Medical (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
Suzhou Jinsheng Plastic Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
Stryker (Suzhou) Medical Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 19
Suzhou Ahno Medical Devices Co., Ltd. Suzhou Jiangsu Contract manufacturer 17

Showing 12 of 53. All 53 manufacturers in China registered for Orthopedic Manual Surgical Instrument

Record

Regulatory record for Integra® Jarit®
Listed by Integra LifeSciences Production Corporation, United States
FDA product code LXH
Device type Orthopedic Manual Surgical Instrument
Device class Class 1
Regulation 21 CFR 888.4540
Establishment Contract manufacturer, Specification developer, Manufacturer
Premarket notification Exempt
Record published 2018-05-02
Record revised 2023-04-25 (version 8)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number
Storage Special storage condition: No
Sizes Length 8 to 13 in; width 1.2 to 63 mm
Distribution end date 2022-05-01

Catalogue Numbers

Catalogue numbers for Integra® Jarit®
Catalogue number Size Status
225323 In distribution
240147 In distribution
240167 In distribution
240232 In distribution
225176 In distribution
240104 In distribution
240118 Length 9 in In distribution
240076 Length 8 in In distribution
225241 In distribution
240187 In distribution
240203 In distribution
240085 Length 8 in In distribution
225301 In distribution
240175 In distribution
240107 In distribution
240072 Length 8 in In distribution
225186 In distribution
240165 In distribution
240125 Length 9 in In distribution
240154 In distribution
240215 In distribution
225135 In distribution
240139 In distribution
240145 In distribution
225461 In distribution
280552 In distribution
240150 In distribution
225332 In distribution
240186 In distribution
225408 In distribution
225178 In distribution
240091 Length 8 in In distribution
240108 In distribution
240177 In distribution
240124 Length 9 in In distribution
240188 In distribution
240202 In distribution
240171 Length 9 in In distribution
240102 In distribution
240120 Length 9 in In distribution
225188 In distribution
240182 In distribution
240196 In distribution
240078 Length 8 in In distribution
270200 In distribution
240148 In distribution
240075 Length 8 in In distribution
225180 In distribution
240144 In distribution
X3892 In distribution
240127 Length 9 in In distribution
225327 In distribution
X38211 In distribution
240-098 6-3/4″ In distribution
225328 In distribution
225462 In distribution
240146 In distribution
240151 In distribution
240214 In distribution
240157 In distribution
225407 In distribution
240074 Length 8 in In distribution
240092 Length 8 in In distribution
270195 In distribution
225179 In distribution
240142 In distribution
225115 In distribution
240095 Length 8 in In distribution
240208 4.2x10mm Cup In distribution
225121 Length 13 in In distribution
240176 In distribution
240172 Length 9 in In distribution
240-099 6-3/4″ In distribution
225314 In distribution
240093 Length 8 in In distribution
240070 Length 8 in In distribution
225324 In distribution
240191 In distribution
270-196 5-7/8″ In distribution
240197 In distribution
X3890 In distribution
240-101 6-3/4″ In distribution
240160 In distribution
240156 In distribution
240123 Length 9 in In distribution
240119 Length 9 in In distribution
240192 In distribution
240166 In distribution
240193 In distribution
240205 7-3/4″ In distribution
225311 In distribution
240230 In distribution
240079 Length 8 in In distribution
225330 In distribution
240140 In distribution
240200 5-1/8″ In distribution
X3807 In distribution
240152 In distribution
240189 In distribution
240077 Length 8 in In distribution
240153 In distribution
225177 In distribution
842620 In distribution
240220 In distribution
240094 Length 8 in In distribution
240212 In distribution
240122 Length 9 in In distribution
240183 In distribution
240138 In distribution
240231 In distribution
240105 In distribution
240086 Length 8 in In distribution
270187 In distribution
225326 In distribution
280554 In distribution
240071 Length 8 in In distribution
240180 In distribution
225325 In distribution
225497 In distribution
240221 In distribution
240143 In distribution
240128 Length 9 in In distribution
240155 In distribution
225333 In distribution
240089 Length 8 in In distribution
225496 8-3/4″ In distribution
240179 In distribution
240126 Length 9 in In distribution
240185 In distribution
X3800 In distribution
225403 Width 13 mm In distribution
240149 In distribution
240198 8-1/2″ In distribution
240073 Length 8 in In distribution
240181 In distribution
240159 In distribution
240141 In distribution
225312 In distribution
240207 4.2x10mm Cup In distribution
225187 In distribution
240216 In distribution
240090 Length 8 in In distribution
240088 Length 8 in In distribution
240103 In distribution
240087 Length 8 in In distribution
225126 In distribution
240162 In distribution
240163 In distribution
240209 4.2x10mm Cup In distribution
225335 In distribution
240211 In distribution
240195 3/8″ Hook In distribution
240-100 6-3/4″ In distribution
240158 In distribution
225190 In distribution
240121 Length 9 in In distribution
240168 In distribution
225463 In distribution
280553 In distribution
240161 In distribution
240178 In distribution
280558 In distribution
240190 In distribution
240164 In distribution
225402 9-3/4″ In distribution
225331 In distribution
240170 Width 1.2 mm In distribution
225313 In distribution
270202 In distribution
225302 In distribution
240080 Length 8 in In distribution
225334 In distribution
X3809UD 7-3/4″ In distribution
270189 In distribution
225498 In distribution
240210 In distribution
270188 In distribution
225329 In distribution
225404 In distribution
240106 In distribution
225400 9-3/4″ In distribution
225405 In distribution
225193 Withdrawn
225192 Withdrawn
225194 Withdrawn
225191 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Razek Equipamentos Razek Equipamentos Ltda 11,578
Orthopedic Manual Surgical Instrument Globus Medical, Inc. 4,784
Instrument Howmedica Osteonics Corp 4,539
Orthopedic Manual Surgical Instrument Ortho Development Corp. 4,076
Knee Instruments Medacta International SA 3,944
Kyocera Medical Technologies, Inc. Kyocera Medical Technologies, Inc. 3,420
Arthrex® Arthrex, Inc. 3,106
Spine Instruments Medacta International SA 2,892
Orthopedic Manual Surgical Instrument Medtronic Sofamor Danek, Inc. 2,766
Hip Instruments Medacta International SA 1,904
Medtronic Reusable Instruments Medtronic Sofamor Danek, Inc. 1,756
ReLine Nuvasive, Inc. 1,208

Showing 12 of 9,501. All products under Orthopedic Manual Surgical Instrument

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