Lucent XP

LUCENT XP® WIDE 12MM x 32MM 10-15° CADDY ASSEMBLY

Registry build 21.09.26
1manufacturer
56catalogue numbers in this listing

Who Else Makes It

Registered in Zhejiang.

Chinese manufacturers registered for FDA product code OJH
Manufacturer City Province Registered as Device types
GRI Medical & Electronic Technology Co., Ltd. Jiaxing Zhejiang Contract manufacturer 71

Record

Regulatory record for Lucent XP
Listed by Spinal Elements, Inc., United States
FDA product code OJH
Device type Orthopedic Tray
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Specification developer, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2024-09-11
Record revised 2023-04-04 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries lot or batch number, manufacturing date
Distribution end date 2024-12-12
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Lucent XP
Catalogue number Size Status
11362-507-02 In distribution
11363-000-02 In distribution
11340-000-01 In distribution
11364-000 In distribution
11364-000-02 In distribution
11367-500 In distribution
11366-000-03 In distribution
11363-000 In distribution
11364-500-01 In distribution
11363-500-01 In distribution
11367-500-01 In distribution
11362-000 In distribution
11340-000-02 In distribution
11365-000-02 In distribution
11363-500 In distribution
11365-000-03 In distribution
11365-000-01 In distribution
11368-000 In distribution
11366-000-02 In distribution
11340-000-03 In distribution
11340-000-04 In distribution
11364-500-02 In distribution
11361-000 In distribution
11361-000-01 In distribution
11340-000 In distribution
11367-500-02 In distribution
11365-000 In distribution
11366-000 In distribution
11361-000-03 In distribution
11362-500 In distribution
11362-000-02 In distribution
11366-000-01 In distribution
11362-507-01 In distribution
11368-000-02 In distribution
11367-000-01 In distribution
11368-000-01 In distribution
11362-500-02 In distribution
11368-500-02 In distribution
11362-000-01 In distribution
11367-000 In distribution
11361-000-02 In distribution
11364-500 In distribution
11368-500-01 In distribution
11363-500-02 In distribution
11367-000-02 In distribution
11363-000-01 In distribution
11362-507 In distribution
11362-500-01 In distribution
11364-000-01 In distribution
11368-500 In distribution
11320-000-01 Withdrawn
11320-000-04 Withdrawn
11320-000-02 Withdrawn
11320-000 Withdrawn
11320-000-03 Withdrawn
11361-000-04 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Cardinal Health Cardinal Health 200, LLC 95,039
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Avid TruCustom Avid Medical, Inc. 3,990
ACS American Contract Systems, Inc. 3,812
Halyard Avid Medical, Inc. 1,313
Aligned Medical Solutions Aligned Medical Solutions 1,272
Regard™ ROi CPS LLC 464
Overwatch Spinal Elements, Inc. 223
Regard™ Resource Optimization & Innovation, L.L.C. 191
Lucent L Spinal Elements, Inc. 95
Invenio GRI Medical & Electronic Technology Co., Ltd. 87
Integra® Ascension Orthopedics, Inc. 81

Showing 12 of 367. All products under Orthopedic Tray

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