Lucent

Lucent® MIS 12MM X 27MM X 14MM 5° Curved Trial, Black

Registry build 21.09.26
53manufacturers in China registered for this device type
363catalogue 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 Lucent
Listed by Spinal Elements, 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, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2019-11-26
Record revised 2023-05-03 (version 8)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, manufacturing date
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Lucent
Catalogue number Size Status
11006-509 In distribution
11048-000 In distribution
81165-048 In distribution
10005-000 In distribution
10005-012 In distribution
11049-000 In distribution
10006-008 In distribution
10014-010 In distribution
10009-010 In distribution
11010-511 In distribution
11012-509 In distribution
10014-009 In distribution
11010-507 In distribution
10006-007 In distribution
10016-011 In distribution
10127-000 In distribution
11077-200 In distribution
11006-507 In distribution
10009-011 In distribution
11004-509 In distribution
11037-000 In distribution
11005-514 In distribution
11035-000 In distribution
11005-510 In distribution
11006-511 In distribution
11041-000 In distribution
11004-516 In distribution
11007-507 In distribution
10011-011 In distribution
11838-009 In distribution
11838-016 In distribution
11033-000 In distribution
11023-507 In distribution
10111-000 In distribution
11838-012 In distribution
10011-014 In distribution
10016-013 In distribution
10160-000 In distribution
10009-009 In distribution
11005-511 In distribution
11009-513 In distribution
11007-510 In distribution
11046-000 In distribution
11013-513 In distribution
11013-507 In distribution
10190-000 In distribution
10046-000 In distribution
10006-009 In distribution
10018-013 In distribution
10005-015 In distribution
11013-514 In distribution
10007-006 In distribution
11023-514 In distribution
10104-000 In distribution
11838-010 In distribution
81165-043 In distribution
81165-033 In distribution
11011-509 In distribution
10007-013 In distribution
11038-000 In distribution
11045-800 In distribution
11005-513 In distribution
10007-009 In distribution
11341-101 In distribution
10113-000 In distribution
10105-000 In distribution
81174-033 In distribution
11004-510 In distribution
10013-009 In distribution
10114-000 In distribution
10014-008 In distribution
10014-013 In distribution
11007-511 In distribution
11010-515 In distribution
81174-028 In distribution
10009-008 In distribution
11838-011 In distribution
11023-510 In distribution
10005-007 In distribution
11008-508 In distribution
10016-005 In distribution
11004-511 In distribution
10032-000 In distribution
11005-516 In distribution
10018-009 In distribution
11011-513 In distribution
10011-013 In distribution
81174-067 In distribution
10017-006 In distribution
11006-508 In distribution
10005-011 In distribution
10137-000 In distribution
10016-007 In distribution
11011-514 In distribution
81165-025 In distribution
81117-000 In distribution
11020-000 In distribution
11008-509 In distribution
10009-006 In distribution
11011-507 In distribution
11045-200 In distribution
11008-510 In distribution
10005-006 In distribution
10133-000 In distribution
10132-000 In distribution
11077-240 In distribution
11009-508 In distribution
10018-005 In distribution
10017-010 In distribution
11013-508 In distribution
81076-000 In distribution
11013-511 In distribution
81116-000 In distribution
10013-008 In distribution
10011-009 In distribution
10015-007 In distribution
11047-440 In distribution
81065-033 In distribution
81197-000 In distribution
10115-000 In distribution
10130-000 In distribution
11005-512 In distribution
10007-012 In distribution
10030-000 In distribution
81166-067 In distribution
81174-043 In distribution
81165-067 In distribution
10034-000 In distribution
11023-513 In distribution
11009-509 In distribution
81174-056 In distribution
11838-015 In distribution
11047-640 In distribution
11305-000 In distribution
81166-088 In distribution
11007-514 In distribution
11004-507 In distribution
10080-000 In distribution
81166-028 In distribution
10015-006 In distribution
81168-012 In distribution
10013-010 In distribution
10006-012 In distribution
10019-007 In distribution
11005-507 In distribution
81165-061 In distribution
10017-014 In distribution
10005-014 In distribution
11023-508 In distribution
10017-007 In distribution
11012-513 In distribution
81174-088 In distribution
81166-037 In distribution
81262-000 In distribution
11016-000 In distribution
11007-509 In distribution
10017-011 In distribution
11010-514 In distribution
10006-005 In distribution
11045-400 In distribution
11153-000 In distribution
11021-000 In distribution
11008-513 In distribution
81115-000 In distribution
81165-028 In distribution
10119-000 In distribution
11011-516 In distribution
11050-001 In distribution
10013-007 In distribution
10018-014 In distribution
10140-000 In distribution
11005-509 In distribution
81166-061 In distribution
10008-000 In distribution
81165-037 In distribution
10007-014 In distribution
10019-008 In distribution
10019-013 In distribution
10108-000 In distribution
11045-801 In distribution
11036-000 In distribution
11011-511 In distribution
11006-515 In distribution
10007-008 In distribution
11006-510 In distribution
11012-510 In distribution
10128-000 In distribution
11012-507 In distribution
10006-011 In distribution
81168-018 In distribution
10018-006 In distribution
10134-000 In distribution
11009-514 In distribution
81166-048 In distribution
11019-000 In distribution
10091-000 In distribution
11341-003 In distribution
10015-013 In distribution
11012-508 In distribution
10070-000 In distribution
10017-009 In distribution
10150-000 In distribution
10006-010 In distribution
11044-000 In distribution
11010-512 In distribution
10018-008 In distribution
11012-512 In distribution
11023-509 In distribution
10019-011 In distribution
11031-000 In distribution
81174-048 In distribution
11040-000 In distribution
10126-000 In distribution
80505-000 In distribution
10019-012 In distribution
11341-102 In distribution
81166-056 In distribution
10014-012 In distribution
10014-007 In distribution
10048-000 In distribution
11004-508 In distribution
11013-510 In distribution
11013-509 In distribution
11077-210 In distribution
81166-043 In distribution
11077-220 In distribution
10010-000 In distribution
11013-512 In distribution
10017-012 In distribution
11008-511 In distribution
81166-025 In distribution
10038-000 In distribution
11042-000 In distribution
11838-014 In distribution
11005-515 In distribution
10118-000 In distribution
11008-514 In distribution
11007-508 In distribution
10013-012 In distribution
11011-510 In distribution
11023-511 In distribution
10011-010 In distribution
10016-006 In distribution
11838-013 In distribution
10200-000 In distribution
10120-000 In distribution
11008-507 In distribution
11010-508 In distribution
10090-000 In distribution
10009-007 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