Invictus

Silicone Handle, Large Tapered Axial, Internal Ratcheting 1/4" SQ., Cannulated, Impacting

Registry build 21.09.26
53manufacturers in China registered for this device type
430catalogue 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 Invictus
Listed by Alphatec Spine, Inc., United States
FDA product code LXH
Device type Orthopedic Manual Surgical Instrument
Device class Class 1
Regulation 21 CFR 888.4540
Establishment Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2021-02-17
Record revised 2023-09-18 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, serial number
Sizes Length 22 to 26 mm
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Invictus
Catalogue number Size Status
18860 In distribution
17180 In distribution
17100-20-4 In distribution
CI-10597 In distribution
17066 In distribution
17835-175 In distribution
16701 In distribution
17072 In distribution
16162 In distribution
CI-10344-02 In distribution
17858 In distribution
17100-25-1 In distribution
16101-20-3 In distribution
17825 In distribution
17059 In distribution
17166-040 In distribution
86003-0500-025-003 In distribution
17046 In distribution
17822 In distribution
86002-0311-001 In distribution
16106 In distribution
17883-R-30 In distribution
17049 In distribution
17100-18-1 In distribution
CI-10344-04 In distribution
17091-01-01 In distribution
17164 In distribution
16711 In distribution
16412 In distribution
17113-25-1 In distribution
17828-500 In distribution
17823-30-30-L In distribution
16129 In distribution
16713 In distribution
16177 In distribution
13073 In distribution
17805 In distribution
17821 In distribution
86033-0210-002 In distribution
16058-03 In distribution
16110-055 In distribution
18814-S In distribution
16417-L In distribution
16153 In distribution
16100-18-3 In distribution
16101-18-2 In distribution
17419-R In distribution
86022-0310-008 In distribution
17093-110 In distribution
17823-45-30-L In distribution
13034 In distribution
86022-0210-008 In distribution
86002-0121-002 In distribution
16172 In distribution
17176 In distribution
17159 In distribution
CI-10605 In distribution
17045 In distribution
16037 In distribution
86033-0210-007 In distribution
17816 In distribution
86002-0121-001 In distribution
16036-01 In distribution
17829-300 In distribution
16023 In distribution
16058-02 In distribution
86022-0310-006 In distribution
17105 In distribution
16710 In distribution
86022-0210-007 In distribution
19840 In distribution
17167-040-T In distribution
13056 In distribution
17823-45-45-L In distribution
17034 In distribution
19852 In distribution
17166-040-T In distribution
86012-0500-025-007 In distribution
17829-150 In distribution
16110-040 In distribution
17820 In distribution
86002-0121-003 In distribution
17189 In distribution
17194 In distribution
86012-0500-025-008 In distribution
17912 In distribution
86022-0210-003 In distribution
18864 In distribution
135-700 In distribution
18840 In distribution
16100-20-1 In distribution
17025 In distribution
13036 In distribution
17826 In distribution
86003-0500-025-008 In distribution
16130 In distribution
18813 In distribution
17092-02-02 In distribution
17146 In distribution
16161 In distribution
17070 In distribution
18821 In distribution
17829-450 In distribution
19821 In distribution
17883-L-30 In distribution
17835-270 In distribution
17150 In distribution
17828-150 In distribution
16008 In distribution
17036 In distribution
17167-050 In distribution
17828-350 In distribution
86022-0310-001 In distribution
17828-100 In distribution
17817 In distribution
13071 In distribution
86012-0500-025-004 In distribution
86003-0500-025-002 In distribution
17142 In distribution
16101-20-2 In distribution
19866 In distribution
17155 In distribution
19831 In distribution
16417-R In distribution
19835 In distribution
17108 In distribution
17426 In distribution
17115 In distribution
17123 In distribution
86022-0210-004 In distribution
17914 In distribution
17100-25-2 In distribution
16150 In distribution
16009 In distribution
86003-0500-025-001 In distribution
16007-06 In distribution
CI-10007 In distribution
17092-01-02 In distribution
13068 In distribution
17169 In distribution
17071 In distribution
17426-N In distribution
17125 In distribution
17171-2 In distribution
17847 In distribution
17122 In distribution
19874 In distribution
18820 In distribution
16107-2 In distribution
17186-22L In distribution
16107-1 In distribution
17091-02-04 In distribution
86022-0310-002 In distribution
CI-10165 In distribution
19828 In distribution
17091-01-02 In distribution
17866 In distribution
86012-0500-025-006 In distribution
17823-60-45-R In distribution
86022-0210-001 In distribution
16189 In distribution
86012-0500-025-002 In distribution
16110-045 In distribution
16408 In distribution
17015 In distribution
17828-450 In distribution
17113-20-4 In distribution
19871 In distribution
16148 In distribution
16058-01 In distribution
17096 In distribution
17818-083 In distribution
86033-0210-003 In distribution
16110-035 In distribution
17090-9 In distribution
16426 In distribution
17091-02 In distribution
13039 In distribution
17113-18-2 In distribution
86033-0210-008 In distribution
17092-02 In distribution
17047 In distribution
17823-60-30-L In distribution
16704 In distribution
18859 In distribution
16111 In distribution
86022-0310-005 In distribution
CI-10046 In distribution
17091-01-03 In distribution
17100-18-4 In distribution
19830 In distribution
17829-250 In distribution
16165 In distribution
16019 In distribution
16007-20 In distribution
17092-01-03 In distribution
16135 In distribution
86002-0121-005 In distribution
17113-20-2 In distribution
17158 In distribution
16186-26 Length 26 mm In distribution
17823-30-45-L In distribution
86002-0311-008 In distribution
17823-30-45-R In distribution
19821-20 In distribution
86002-0315-002 In distribution
17167-045-T In distribution
17100-18-2 In distribution
16171 In distribution
17167-055 In distribution
17032 In distribution
17829-500 In distribution
17823-45-30-R In distribution
16136 In distribution
86002-0500-025-008 In distribution
17157 In distribution
19872 In distribution
17093-090 In distribution
16100-20-3 In distribution
16100-20-2 In distribution
17808 In distribution
17100-20-3 In distribution
16186-22 Length 22 mm In distribution
18861 In distribution
17186-22 In distribution
17823-60-45-L In distribution
17823-30-30-R In distribution
16193 In distribution
17823-45-00 In distribution
16003 In distribution
17823-60-30-R In distribution
16152 In distribution
16132 In distribution
16117 In distribution
16101-20-1 In distribution
86012-0500-025-003 In distribution
17065 In distribution
16012 In distribution
86002-0311-002 In distribution
19813 In distribution
17170-2 In distribution
19860 In distribution
17171 In distribution
17113-25-2 In distribution
17167-035-T In distribution
CI-10344-03 In distribution
18832 In distribution
16107-3 In distribution
86002-0311-003 In distribution
16101-18-4 In distribution

Showing 250 of 300 catalogue numbers.

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