Firebird SFS

Firebird Spinal Fixation System, DDD Instrument Case 3 With Distractor (44-9040)

Registry build 21.09.26
53manufacturers in China registered for this device type
196catalogue 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 Firebird SFS
Listed by Orthofix US LLC, 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 2019-03-12
Record revised 2026-02-20 (version 4)

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
Latex Labelled latex-free
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for Firebird SFS
Catalogue number Size Status
450364-0001 In distribution
90-7606 In distribution
450321-0001 In distribution
90-7607 In distribution
52-1004 In distribution
90-7584 In distribution
44-0070 In distribution
450232-0001 In distribution
44-0110 In distribution
450387-0001 In distribution
44-0012 In distribution
44-0117 In distribution
450304-0001 In distribution
90-7574 In distribution
52-1581 In distribution
90-7591 In distribution
90-7573 In distribution
450388-0001 In distribution
450323-0001 In distribution
44-0102 In distribution
52-1755 In distribution
450399-0001 In distribution
52-1042 In distribution
450392-0001 In distribution
450198-0005 In distribution
44-0108 In distribution
450352-0001 In distribution
90-7569 In distribution
52-1512 In distribution
36-8100 In distribution
450202-0002 In distribution
90-7576 In distribution
44-0109 In distribution
90-7577 In distribution
51-1486 In distribution
90-4892 In distribution
450307-0001 In distribution
51-0080 In distribution
51-1986 In distribution
90-7600 In distribution
61-2265 In distribution
61-2038 In distribution
90-7578 In distribution
450383-0001 In distribution
450201-0002 In distribution
450199-0004 In distribution
51-1989 In distribution
450353-0001 In distribution
90-7568 In distribution
52-1012 In distribution
52-1391 In distribution
450389-0001 In distribution
51-1980 In distribution
450363-0001 In distribution
90-6471 In distribution
450412-0001 In distribution
450350-0001 In distribution
90-7570 In distribution
51-1455 In distribution
52-1010 In distribution
44-0105 In distribution
90-7581 In distribution
61-2255 In distribution
450280-0005 In distribution
90-4893 In distribution
450322-0001 In distribution
450312-0001 In distribution
44-0103 In distribution
90-7550 In distribution
54-1068 In distribution
90-7571 In distribution
90-7594 In distribution
90-7551 In distribution
61-2092 In distribution
450394-0001 In distribution
52-1094 In distribution
90-6473 In distribution
450407-0001 In distribution
450395-0001 In distribution
44-0104 In distribution
450202-0003 In distribution
44-0116 In distribution
450332-0003 In distribution
44-0080 In distribution
44-0106 In distribution
450320-0001 In distribution
450393-0001 In distribution
51-0560 In distribution
90-7601 In distribution
90-7603 In distribution
44-0050 In distribution
450280-0006 In distribution
450362-0001 In distribution
450406-0001 In distribution
51-0590 In distribution
51-1488 In distribution
52-1393 In distribution
90-7585 In distribution
52-1038 In distribution
90-7598 In distribution
90-7604 In distribution
450410-0001 In distribution
450400-0001 In distribution
61-2037 In distribution
52-1205 In distribution
61-2007 In distribution
51-0580 In distribution
51-0060 In distribution
52-1005 In distribution
44-0040 In distribution
52-1093 In distribution
51-1988 In distribution
90-7579 In distribution
52-1097 In distribution
61-1265 In distribution
90-7575 In distribution
44-0111 In distribution
44-0112 In distribution
44-0030 In distribution
51-1423 In distribution
450197-0003 In distribution
450397-0001 In distribution
90-7549 In distribution
450333-0002 In distribution
450332-0002 In distribution
44-0013 In distribution
61-0112 In distribution
90-7580 In distribution
90-7592 In distribution
90-7588 In distribution
52-1392 In distribution
52-1080 In distribution
44-0115 In distribution
52-1092 In distribution
450202-0001 In distribution
51-1987 In distribution
90-7589 In distribution
90-6476 In distribution
52-1334 In distribution
90-4890 In distribution
450386-0001 In distribution
90-6469 In distribution
90-6474 In distribution
90-6475 In distribution
450231-0001 In distribution
52-1081 In distribution
51-1990 In distribution
51-1487 In distribution
90-7586 In distribution
450351-0001 In distribution
90-6472 In distribution
52-1095 In distribution
450351-0002 In distribution
450403-0001 In distribution
450411-0001 In distribution
450390-0001 In distribution
44-0010 In distribution
450261-0001 In distribution
450385-0001 In distribution
450260-0001 In distribution
90-7572 In distribution
90-7587 In distribution
51-1480 In distribution
450408-0001 In distribution
450293-0001 In distribution
450409-0001 In distribution
90-7583 In distribution
90-6468 In distribution
450402-0001 In distribution
90-7593 In distribution
450382-0001 In distribution
450384-0001 In distribution
52-1251 In distribution
450405-0001 In distribution
52-1255 In distribution
44-0060 In distribution
450396-0001 In distribution
450200-0002 In distribution
450391-0001 In distribution
450398-0001 In distribution
450404-0001 In distribution
51-0090 In distribution
44-0011 In distribution
450447-0001 In distribution
61-2093 In distribution
450413-0001 In distribution
90-7582 In distribution
44-0020 In distribution
450401-0001 In distribution
52-1204 In distribution
90-6470 In distribution
44-0107 In distribution
61-0060 In distribution
44-0114 In distribution
44-0113 In distribution
61-0400 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