Orthomed

Swing Apart Kerrison Rongeur 8" TFP 40 DEG FWD 2MM EB

Registry build 21.09.26
9manufacturers in China registered for this device type
228catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (3), Shanghai (2), Guangdong (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code LRY
Manufacturer City Province Registered as Device types
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Paragon Medical Device (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 53
B.Braun Medical (Suzhou) Co,.Ltd Suzhou Jiangsu Contract manufacturer 37
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Arthrex (Shanghai) Co., Ltd. Shanghai Shanghai Exporter 38
Suzhou Microport Orthorecon Co., Ltd. Suzhou Jiangsu Contract manufacturer 31
Guangzhou Aquila Precise Tools Limited Guangzhou Guangdong Contract manufacturer 28
Tonglu Wanhe Medical Instrument Co., Ltd. Hangzhou Zhejiang Manufacturer 24

Record

Regulatory record for Orthomed
Listed by Ortho-MED, Inc., United States
FDA product code LRY
Device type Punch, Surgical
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Repacker / relabeller
Premarket notification Exempt
Record published 2023-08-22
Record revised 2024-06-20 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Label carries lot or batch number
Distribution end date 2026-07-22

Catalogue Numbers

Catalogue numbers for Orthomed
Catalogue number Size Status
OM 47-0860 In distribution
OM 47-0676 In distribution
OM 55-0947 In distribution
OM 48-0032 In distribution
OM 59-0306 In distribution
OM 29-0512 In distribution
OM 47-0858 In distribution
OM 55-0815 In distribution
OM 47-0874 In distribution
OM 59-0315 In distribution
OM 55-0895 In distribution
OM 55-0973 In distribution
OM 48-0027 In distribution
OM 55-0767 In distribution
OM 55-0929 In distribution
OM 47-0702 In distribution
OM 59-0313 In distribution
OM 47-0671 In distribution
OM 55-0942 In distribution
OM 47-0784 In distribution
OM 55-0690 In distribution
OM 29-0515 In distribution
OM 47-0992 In distribution
OM 55-0961 In distribution
OM 55-0967 In distribution
OM 55-0858 In distribution
OM 47-0879 In distribution
OM 55-0980 In distribution
OM 55-0901 In distribution
OM 47-0736 In distribution
OM 47-0999 In distribution
OM 47-0740 In distribution
OM 62-0412 In distribution
OM 29-0517 In distribution
OM 55-0904 In distribution
OM 47-0657 In distribution
OM 47-0648 In distribution
OM 62-0222 In distribution
OM 55-0966 In distribution
OM 55-0782 In distribution
OM 59-0315E In distribution
OM 59-0122 In distribution
OM 47-0700 In distribution
OM 55-0981 In distribution
OM 47-0991 In distribution
OM 59-0321E In distribution
OM 47-0654 In distribution
OM 62-0225 In distribution
OM 55-0870 In distribution
OM 47-0649 In distribution
OM 59-0115 In distribution
OM 47-0864 In distribution
OM 55-0691 In distribution
OM 55-0936 In distribution
OM 47-0708 In distribution
OM 55-0954 In distribution
OM 47-0645 In distribution
OM 47-0644 In distribution
OM 48-0021 In distribution
OM 47-0804 In distribution
OM 55-0891 In distribution
OM 59-0309 In distribution
OM 55-0974 In distribution
OM 47-0688 In distribution
OM 55-0905 In distribution
OM 55-0964 In distribution
OM 47-0710 In distribution
OM 47-0842 In distribution
OM 55-0892 In distribution
OM 47-0764 In distribution
OM 47-0712 In distribution
OM 59-0321 In distribution
OM 47-0988 In distribution
OM 47-0760 In distribution
OM 55-0919 In distribution
OM 47-0742 In distribution
OM 55-0917 In distribution
OM 55-0962 In distribution
OM 47-0707 In distribution
OM 55-0694 In distribution
OM 47-0689 In distribution
OM 47-0704 In distribution
OM 48-0020 In distribution
OM 29-0511 In distribution
OM 47-0732 In distribution
OM 55-0946 In distribution
OM 48-0030 In distribution
OM 48-0033 In distribution
OM 55-0948 In distribution
OM 47-0989 In distribution
OM 47-0993 In distribution
OM 47-0650 In distribution
OM 47-0802 In distribution
OM 62-0414 In distribution
OM 59-0312 In distribution
OM 48-0018 In distribution
OM 55-0871 In distribution
OM 55-0916 In distribution
OM 48-0024 In distribution
OM 47-0714 In distribution
OM 47-0734 In distribution
OM 59-0322 In distribution
OM 55-0908 In distribution
OM 47-0782 In distribution
OM 55-0972 In distribution
OM 48-0017 In distribution
OM 47-0680 In distribution
OM 55-0693 In distribution
OM 59-0124 In distribution
OM 55-0910 In distribution
OM 62-0224 In distribution
OM 29-0514 In distribution
OM 55-0825 In distribution
OM 55-0906 In distribution
OM 47-0853 In distribution
OM 47-0994 In distribution
OM 47-0844 In distribution
OM 55-0872 In distribution
OM 55-0925 In distribution
OM 55-0941 In distribution
OM 55-0928 In distribution
OM 48-0028 In distribution
OM 29-0513 In distribution
OM 55-0918 In distribution
OM 47-0610 In distribution
OM 55-0952 In distribution
OM 59-0113 In distribution
OM 47-0857 In distribution
OM 48-0025 In distribution
OM 47-0873 In distribution
OM 59-0123 In distribution
OM 47-0875 In distribution
OM 59-0125 In distribution
OM 62-0413 In distribution
OM 59-0114 In distribution
OM 55-0960 In distribution
OM 55-0912 In distribution
OM 47-0709 In distribution
OM 47-0998 In distribution
OM 47-0868 In distribution
OM 62-0221 In distribution
OM 55-0953 In distribution
OM 47-0738 In distribution
OM 47-0872 In distribution
OM In distribution
OM 47-0686 In distribution
OM 62-0411 In distribution
OM 55-0914 In distribution
OM 55-0935 In distribution
OM 55-0949 In distribution
OM 48-0022 In distribution
OM 47-0990 In distribution
OM 55-0909 In distribution
OM 55-0940 In distribution
OM 62-0223 In distribution
OM 47-0744 In distribution
OM 47-0730 In distribution
OM 59-0323 In distribution
OM 48-0026 In distribution
OM 47-0616 In distribution
OM 47-0670 In distribution
OM 48-0041 In distribution
OM 55-0898 In distribution
OM 55-0937 In distribution
OM 48-0023 In distribution
OM 47-0652 In distribution
OM 59-0310 In distribution
OM 47-0658 In distribution
OM 48-0010 In distribution
OM 47-0996 In distribution
OM 48-0016 In distribution
OM 55-0857 In distribution
OM 47-0612 In distribution
OM 47-0878 In distribution
OM 59-0121 In distribution
OM 59-0303 In distribution
OM 59-0126 In distribution
OM 47-0800 In distribution
OM 47-0866 In distribution
OM 55-0963 In distribution
OM 59-0112 In distribution
OM 55-0915 In distribution
OM 47-0614 In distribution
OM 47-0780 In distribution
OM 55-0788 In distribution
OM 47-0682 In distribution
OM 55-0762 In distribution
OM 47-0997 In distribution
OM 59-0316 In distribution
OM 47-0856 In distribution
OM 48-0040 In distribution
OM 47-0674 In distribution
OM 55-0938 In distribution
OM 59-0111 In distribution
OM 47-0687 In distribution
OM 59-0322E In distribution
OM 47-0678 In distribution
OM 59-0316E In distribution
OM 47-0646 In distribution
OM 47-0995 In distribution
OM 47-0685 In distribution
OM 47-0762 In distribution
OM 55-0790 In distribution
OM 55-0800 In distribution
OM 55-0823 In distribution
OM 55-0913 In distribution
OM 62-0415 In distribution
OM 55-0856 In distribution
OM 59-0116 In distribution
OM 55-0777 In distribution
OM 47-0855 In distribution
OM 59-0313E In distribution
OM 55-0926 In distribution
OM 55-0911 In distribution
OM 47-0870 In distribution
OM 55-0842 In distribution
OM 48-0029 In distribution
OM 47-0840 In distribution
OM 55-0860 In distribution
OM 47-0656 In distribution
OM 55-0927 In distribution
OM 55-0813 In distribution
OM 55-0763 In distribution
OM 48-0019 In distribution
OM 47-0862 In distribution
OM 48-0042 In distribution
OM 59-0300 In distribution
OM 59-0316 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
RZ Medizintechnik GmbH RZ Medizintechnik Gmbh 693
Ambler Surgical Ambler Surgical, LLC 317
Aesculap Aesculap AG 187
Lazic Peter Lazic Gmbh 148
Noir Aesculap AG 66
MaxMoreSpine Hoogland Spine Products GmbH 44
Kerrison Elliquence LLC 36
Integra® Miltex® Integra LifeSciences Production Corporation 33
Punch, Surgical Doppkon Gmbh & Co. KG 29
Scharf Scharf Tools Ihracat Ithalat Limited Sirketi 29
Henry Schein Henry Schein, Inc. 27
ACE Ace Surgical Supply Co., Inc. 25

Showing 12 of 216. All products under Punch, Surgical

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