PGI

PGI II Curette, Bayonetted Down Sharp Lg

Registry build 21.09.26
53manufacturers in China registered for this device type
92catalogue 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 PGI
Listed by Nuvasive, 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 2018-09-24
Record revised 2025-06-11 (version 5)

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

Catalogue Numbers

Catalogue numbers for PGI
Catalogue number Size Status
1667599 In distribution
1667609 In distribution
1007024 In distribution
7100149 In distribution
1667684 In distribution
1667674 In distribution
1007026 In distribution
1667598 In distribution
1008948 In distribution
1667593 In distribution
1667662 In distribution
7100146 In distribution
5010120 In distribution
1667686 In distribution
1667606 In distribution
7100054 In distribution
1667797 In distribution
7100055 In distribution
1667700 In distribution
1667595 In distribution
1667652 In distribution
1667592 In distribution
1007029 In distribution
1667597 In distribution
7100150 In distribution
7100121 In distribution
7100156 In distribution
1667755 In distribution
1667798 In distribution
7101041 In distribution
1667774 In distribution
1667691 In distribution
7100122 In distribution
1667645 In distribution
1667698 In distribution
1667752 In distribution
1007022 In distribution
5001001 In distribution
1667676 In distribution
1667753 In distribution
1009522 In distribution
1667672 In distribution
1667784 In distribution
1667782 In distribution
1667795 In distribution
1667772 In distribution
1667682 In distribution
1667790 In distribution
1667590 In distribution
1667793 In distribution
1008947 In distribution
1667640 In distribution
1667791 In distribution
8801371 In distribution
7100148 In distribution
1667630 In distribution
1667776 In distribution
1667696 In distribution
1667653 In distribution
7130120 In distribution
1667690 In distribution
1667699 In distribution
1667596 In distribution
1667697 In distribution
1667745 In distribution
1667608 In distribution
1667635 In distribution
7100120 In distribution
1667799 In distribution
7101042 In distribution
1667740 In distribution
1667695 In distribution
1667794 In distribution
1667692 In distribution
1667594 In distribution
7100157 In distribution
1009521 In distribution
1667591 In distribution
1667792 In distribution
1010244 In distribution
1008949 In distribution
1667694 In distribution
1667754 In distribution
1667796 In distribution
1667667 In distribution
1667654 In distribution
1667655 In distribution
7100147 In distribution
1667607 In distribution
1667786 In distribution
1667693 In distribution
1667750 In distribution

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