Aleutian® Interbody Systems

AN Lordotic Oblique Inserter Full Lateral Tip Size 8.5x32 mm

Registry build 21.09.26
53manufacturers in China registered for this device type
972catalogue 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 Aleutian® Interbody Systems
Listed by VB Spine LLC
FDA product code LXH
Device type Orthopedic Manual Surgical Instrument
Device class Class 1
Regulation 21 CFR 888.4540
Premarket notification Exempt
Record published 2020-02-05
Record revised 2026-04-20 (version 6)

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
Label carries lot or batch number, expiry date
Sizes Height 4 to 37 mm; width 4 to 40 mm; length 10 to 305 mm; angle 5 to 30 °
Distribution end date 2025-12-30

Catalogue Numbers

Catalogue numbers for Aleutian® Interbody Systems
Catalogue number Size Status
SP-4085-46 Angle 6 ° In distribution
K2-32-2003-07 In distribution
602-90235 Height 9 mm In distribution
602-90233 Height 7 mm In distribution
602-90287 In distribution
SP-4232-01 Width 8 mm In distribution
3201-90130 Height 12 mm In distribution
SP-728 In distribution
702-90065 In distribution
3303-90064 In distribution
K2-33-2013-02 In distribution
702-90159 In distribution
SP-1605-06 Width 30 mm In distribution
SP-2070-01 In distribution
PRO-1143-26 Height 19 mm In distribution
3201-90128 Height 10 mm In distribution
SP-4085-05 Width 8.5 mm In distribution
SP-4040 In distribution
3201-90134 Height 16 mm In distribution
SP-4085-70 Length 24 mm In distribution
702-90096 In distribution
5203-90167 In distribution
SP-2118-03 Width 12 mm In distribution
PRO-1143-21 Height 14 mm In distribution
SP-4085-16 Length 22 mm In distribution
PRO-1302-07 Cup Size 4/0 In distribution
502-90052 Length 27 mm In distribution
K2-33-2006-02 In distribution
K2-33-2010-02 In distribution
602-90006 In distribution
702-90003 In distribution
702-90208 In distribution
3303-90030 In distribution
SP-4084-05 Height 11 mm In distribution
K2-33-2030-02 In distribution
SP-4085-63 Height 10 mm In distribution
K2-32-2038-03 Width 18 mm In distribution
602-90509 In distribution
5303-90058 In distribution
402-90317 In distribution
PRO-1302-03 Cup Size 4/0 In distribution
3201-90143 Height 10 mm In distribution
SP-4084-06 Height 12 mm In distribution
3201-90308 In distribution
5203-90151 In distribution
5303-90078 In distribution
3303-90032 In distribution
K2-32-2039-04 In distribution
SP-4127-02 Angle 8 ° In distribution
602-90031 Width 13 mm In distribution
PRO-1230-03 In distribution
K2-07-2069-04 In distribution
5303-90000 In distribution
K2-32-2007-07 In distribution
SP-2309-07 Width 30 mm In distribution
602-90226 In distribution
PRO-1241-01 In distribution
K2-32-2041-12 In distribution
3201-90313 In distribution
SP-4085-15 Height 4 mm In distribution
PRO-1009-03 Angle 12 ° In distribution
SP-4193-10 Height 16 mm In distribution
602-90017 Width 9 mm In distribution
SP-4085-56 Height 17 mm In distribution
3201-90333 Height 16 mm In distribution
SP-4085-83 Length 24 mm In distribution
SP-2069-03 In distribution
SP-4031-10 Height 15 mm In distribution
5203-90100 In distribution
K2-33-2028-01 In distribution
SP-4031-08 Height 13 mm In distribution
PRO-1143-27 Height 7 mm In distribution
SP-4085-76 Width 8.5 mm In distribution
5303-90111 In distribution
K2-32-2039-11 Height 12 mm In distribution
402-90314 In distribution
602-90030 Width 12 mm In distribution
602-90272 In distribution
SP-4013-03 Height 9 mm In distribution
5303-90008 In distribution
602-90257 Height 8 mm In distribution
3303-90075 In distribution
PRO-1302-01 Cup Size 2/0 In distribution
602-90003 In distribution
PRO-1169-08 Width 13 mm In distribution
SP-2309-04 Height 15 mm In distribution
SP-4085-02 Height 5 mm In distribution
PRO-1143-34 Height 14 mm In distribution
5303-90054 In distribution
3303-90044 In distribution
SP-4193-03 Height 9 mm In distribution
5303-90026 In distribution
3303-90034 In distribution
K2-32-2004-03 In distribution
PRO-1241-02 In distribution
602-90027 Width 9 mm In distribution
K2-32-2039-20 In distribution
SP-3157-04 Length 24 mm In distribution
PRO-1143-05 Height 11 mm In distribution
3201-90377 Length 60 mm In distribution
3303-90061 In distribution
SP-4192 #4 Cup Size In distribution
3201-90317 Width 18 mm In distribution
702-90210 In distribution
5203-90111 In distribution
SP-4210-04 Height 10 mm In distribution
602-90501 In distribution
SP-4085-07 Width 8.5 mm In distribution
602-90500 In distribution
3201-90294 In distribution
3201-90357 Length 60 mm In distribution
SP-4085-48 Height 9 mm In distribution
602-90091 In distribution
SP-4075-01 In distribution
K2-32-2006-09 In distribution
702-90166 In distribution
K2-32-2038-07 Height 10 mm In distribution
3201-90272 In distribution
K2-32-2039-08 In distribution
3201-91011 Height 5 mm In distribution
PRO-1009-10 Length 28 mm In distribution
5303-90056 In distribution
602-90066 In distribution
702-90079 In distribution
K2-32-2038-15 Length 50 mm In distribution
SP-4085-65 Width 8.5 mm In distribution
3201-90413 Angle 8 ° In distribution
3303-90019 In distribution
SP-4013-08 Height 14 mm In distribution
PRO-1058-02 In distribution
5303-90004 In distribution
702-90163 In distribution
5303-90012 In distribution
PRO-1170-01 In distribution
602-90267 In distribution
SP-3196-03 Height 15 mm In distribution
602-90088 In distribution
602-90225 In distribution
SP-4060-02 Width 8 mm In distribution
502-90054 Width 10 mm In distribution
702-90099 In distribution
PRO-1143-18 Height 11 mm In distribution
PRO-1009-08 Width 8.5 mm In distribution
SP-4013-10 Height 16 mm In distribution
PRO-1141-01 Height 33 mm In distribution
3201-90141 Height 8 mm In distribution
602-90262 Height 13 mm In distribution
3303-90160 In distribution
K2-32-2056-03 In distribution
SP-4013-09 Height 15 mm In distribution
602-90263 Height 15 mm In distribution
K2-07-2100-02 In distribution
602-90033 Width 17 mm In distribution
SP-4085-38 Angle 18 ° In distribution
SP-3157-05 Angle 15 ° In distribution
SP-2069-04 In distribution
3303-90074 In distribution
SP-4244-09 Angle 30 ° In distribution
K2-04-2062-02 Width 14 mm In distribution
PRO-1143-12 Height 18 mm In distribution
SP-4031-05 Height 10 mm In distribution
502-90049 Width 10 mm In distribution
SP-1605-01 Width 5 mm In distribution
PRO-1169-07 Width 12 mm In distribution
3303-90066 In distribution
PRO-1143-25 Height 18 mm In distribution
3201-90304 In distribution
SP-4031-11 Height 16 mm In distribution
SP-3196-02 Length 28 mm In distribution
5203-90129 In distribution
3201-91002 Height 13 mm In distribution
602-90507 In distribution
602-90273 In distribution
5203-90009 In distribution
5303-90040 In distribution
602-90264 In distribution
PRO-1009-11 Width 8.5 mm In distribution
3303-90024 In distribution
5203-90157 In distribution
PRO-1062-02 Width 19 mm In distribution
3303-90153 In distribution
PRO-1306-06 Width 10 mm In distribution
602-90043 Width 4 mm In distribution
SP-4085-68 Width 8.5 mm In distribution
5303-90101 In distribution
702-90181 In distribution
3303-90062 In distribution
602-90271 In distribution
5303-90094 In distribution
PRO-1143-13 Height 19 mm In distribution
5203-90169 In distribution
5303-90014 In distribution
602-90005 In distribution
SP-4031-07 Height 12 mm In distribution
3201-90797 Length 60 mm In distribution
PRO-1143-01 Height 7 mm In distribution
5203-90113 In distribution
602-90239 Height 13 mm In distribution
3201-90325 Height 12 mm In distribution
3303-90058 In distribution
5303-90109 In distribution
K2-32-2038-08 In distribution
K2-32-2052-04 In distribution
SP-4085-12 Length 22 mm In distribution
SP-1605-04 Width 20 mm In distribution
K2-32-2051-08 In distribution
SP-4084-08 Height 14 mm In distribution
PRO-1143-37 Height 17 mm In distribution
SP-4127-09 Angle 8 ° In distribution
K2-33-2013-03 In distribution
SP-4127-13 Angle 8 ° In distribution
K2-32-2041-15 Width 22 mm In distribution
402-90331 Width 14 mm In distribution
K2-32-2052-12 In distribution
K2-33-2009-01 In distribution
K2-32-2052-01 In distribution
PRO-1170-02 In distribution
K2-04-2062-07 In distribution
SP-4127-04 Angle 8 ° In distribution
3201-90296 In distribution
K2-32-2006-07 In distribution
K2-32-2040-03 Length 50 mm In distribution
K2-04-2062-04 Length 11 mm In distribution
702-90214 In distribution
3201-91010 Height 4 mm In distribution
602-90075 In distribution
SP-3157-06 Length 24 mm In distribution
PRO-1306-11 Width 16 mm In distribution
602-90063 In distribution
602-90234 Height 8 mm In distribution
SP-4084-01 Height 7 mm In distribution
SP-4193-09 Height 15 mm In distribution
402-90335 Length 11 mm In distribution
5203-90101 In distribution
K2-33-2017-01 In distribution
602-90089 In distribution
SP-2309-02 Height 11 mm In distribution
K2-32-2039-07 Width 18 mm In distribution
K2-33-2002-01 In distribution
PRO-1143-19 Height 12 mm In distribution
602-90072 In distribution
3303-90023 In distribution
PRO-1302-05 Cup Size 2/0 In distribution
SP-4127-15 Height 20 mm In distribution
PRO-1143-08 Height 14 mm In distribution
602-90310 In distribution
K2-33-2030-01 In distribution
K2-33-2006-01 In distribution
PRO-1169-02 Width 7 mm In distribution
5303-90116 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