Panta® 2

Arthrodesis Nail System AO Driver Shaft - 3.5mm Hex Screwdriver, Self-Retaining

Registry build 21.09.26
53manufacturers in China registered for this device type
38catalogue 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 Panta® 2
Listed by Ascension Orthopedics, Inc., United States
FDA product code LXH
Device type Orthopedic Manual Surgical Instrument
Device class Class 1
Regulation 21 CFR 888.4540
Establishment Manufacturer
Premarket notification Exempt
Record published 2018-11-13
Record revised 2023-03-14 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number
Storage Special storage condition: Do Not Use if Package is Damaged
Distribution end date 2026-12-31

Catalogue Numbers

Catalogue numbers for Panta® 2
Catalogue number Size Status
PAN-1010-0230 In distribution
PAN-1010-0187 In distribution
PAN-1010-0019 13mm In distribution
PAN-1010-0120 In distribution
PAN-1010-0183 ø7mm, Calcaneal In distribution
PAN-1010-0188 4.1mm In distribution
PAN-1010-0015 ø11.5mm In distribution
PAN-1010-0029 ø9mm In distribution
PAN-1010-0201 In distribution
PAN-1010-0034 ø3.2mm x 600mm In distribution
PAN-1010-0004 ø4.1mm In distribution
PAN-1010-0175 ø5mm In distribution
PAN-1010-0113 In distribution
PAN-1010-0007 ø7mm x 185mm In distribution
PAN-1010-0186 ø4.1mm, Tibial In distribution
PAN-1010-0028 ø3.2mm In distribution
PAN-1010-0122 In distribution
PAN-1010-0012 ø12 mm In distribution
PAN-1010-0014 ø10.5mm In distribution
PAN-1010-0121 In distribution
PAN-1010-0181 ø5mm In distribution
PAN-1010-0011 ø11mm In distribution
PAN-1010-0160 In distribution
PAN-1010-0184 ø7mm, Tibia In distribution
PAN-1010-0003 ø4.1mm In distribution
PAN-1010-0010 ø10mm In distribution
HTM0111-S01 In distribution
PAN-1010-0013 ø13 mm In distribution
PAN-1010-0009 ø9mm x 185mm In distribution
PAN-1010-0185 ø4.1mm, Calcaneal In distribution
PAN-1010-0030 ø13.5mm In distribution
PAN-1010-0017 ø13.5mm In distribution
PAN-1010-0231 In distribution
PAN-1010-0135 In distribution
PAN-1010-0190 3.5mm Hex In distribution
PAN-1010-0002 ø4.1mm In distribution
PAN-1010-0210 ø2.5mm x 150mm In distribution
PAN-1010-0016 ø12.5mm 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