Orthopedic › ProstheticIntervertebral Fusion Device With Integrated Fixation, Cervical

Paramount™ Anterior Cervical Spine System

Paramount™ Cage and Plate Assembly, Lordotic, 10 mm (H) x 15.5 mm (W) x 14 mm (L)

Registry build 21.09.26
5manufacturers in China registered for this device type
146catalogue numbers in this listing
2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Zhejiang (2), Guangdong (1), Jiangsu (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code OVE
Manufacturer City Province Registered as Device types
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Zibo Dante Co., Ltd. Zibo Shandong Contract manufacturer 17
Zhisu Health Tech Jiaxing Co., Ltd. Tongxiang Zhejiang Contract manufacturer 4
Medtronic (Changzhou) Medical Devices Technology Co., Ltd. Changzhou Jiangsu Manufacturer 53
Zhejiang Decans Medical Devices Co., Ltd. Jiaxing Zhejiang Manufacturer 10

Record

Regulatory record for Paramount™ Anterior Cervical Spine System
Listed by Spine Wave, Inc., United States
FDA product code OVE
Device type Intervertebral Fusion Device With Integrated Fixation, Cervical
Device class Class 2
Regulation 21 CFR 888.3080
Establishment Specification developer, Repacker / relabeller, Manufacturer
510(k) K162760
Record published 2017-09-13
Record revised 2024-09-11 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date
Sizes Width 14 to 15.5 mm; height 5 to 10 mm; length 12 to 14 mm

Catalogue Numbers

Catalogue numbers for Paramount™ Anterior Cervical Spine System
Catalogue number Size Status
10-5649 In distribution
11-5589 Width 14 mm In distribution
10-9024 In distribution
10-5602 In distribution
10-9026 In distribution
21-8924 Height 9 mm In distribution
10-9020 In distribution
11-5549 Length 13 mm In distribution
10-9032 In distribution
10-5623 In distribution
11-5517 Width 14 mm In distribution
10-9042 In distribution
10-9048 In distribution
10-9060 In distribution
10-5600 In distribution
21-8955 Height 8 mm In distribution
11-5576 Length 13 mm In distribution
11-5516 Length 13 mm In distribution
21-8940 Length 14 mm In distribution
11-5513 Width 14 mm In distribution
11-5540 Length 13 mm In distribution
10-9031 In distribution
11-5521 Width 14 mm In distribution
11-5541 Width 14 mm In distribution
21-8938 Length 14 mm In distribution
10-9021 In distribution
21-8968 Height 5 mm In distribution
21-9009 Width 14 mm In distribution
10-5617 In distribution
10-5492 In distribution
10-9035 In distribution
10-5652 In distribution
10-5612 In distribution
21-9014 Height 10 mm In distribution
11-5590 Length 13 mm In distribution
10-5630 In distribution
21-8969 Length 14 mm In distribution
10-5615 In distribution
10-5632 In distribution
10-5490 In distribution
11-5518 Length 13 mm In distribution
11-5544 Length 13 mm In distribution
10-5601 In distribution
21-8937 Height 6 mm In distribution
21-9021 Width 15.5 mm In distribution
10-5604 In distribution
21-9017 Width 15.5 mm In distribution
10-5614 In distribution
10-5611 In distribution
11-5597 Width 14 mm In distribution
10-5629 In distribution
10-9036 In distribution
10-5650 In distribution
10-5628 In distribution
10-9023 In distribution
21-8921 Length 12 mm In distribution
21-8920 Height 5 mm In distribution
11-5596 Length 13 mm In distribution
11-5591 Width 14 mm In distribution
10-5627 In distribution
11-5575 Width 14 mm In distribution
10-9034 In distribution
10-5661 In distribution
21-8925 Length 12 mm In distribution
10-5489 In distribution
10-9049 In distribution
11-5566 Length 13 mm In distribution
21-9013 Width 14 mm In distribution
10-9043 In distribution
21-8936 Length 14 mm In distribution
10-9056 In distribution
10-5653 In distribution
10-9022 In distribution
10-9039 In distribution
10-5624 In distribution
10-9033 In distribution
11-5550 Width 14 mm In distribution
11-5574 Length 13 mm In distribution
21-9018 Height 6 mm In distribution
21-8952 Length 12 mm In distribution
21-9011 Width 14 mm In distribution
11-5568 Length 13 mm In distribution
10-9029 In distribution
10-5599 In distribution
21-8941 Height 10 mm In distribution
21-8971 Length 14 mm In distribution
10-9041 In distribution
21-9012 Height 8 mm In distribution
11-5551 Length 13 mm In distribution
11-5542 Length 13 mm In distribution
10-9025 In distribution
11-5511 Width 14 mm In distribution
11-5598 Length 13 mm In distribution
21-9019 Width 15.5 mm In distribution
21-8954 Length 12 mm In distribution
10-5608 In distribution
21-8923 Length 12 mm In distribution
11-5512 Length 13 mm In distribution
11-5567 Width 14 mm In distribution
10-5631 In distribution
21-8922 Height 7 mm In distribution
11-5519 Width 14 mm In distribution
10-9027 In distribution
10-9037 In distribution
10-5607 In distribution
11-5510 Length 13 mm In distribution
10-9047 In distribution
21-8953 Height 6 mm In distribution
11-5588 Length 13 mm In distribution
10-5605 In distribution
10-9038 In distribution
10-9045 In distribution
10-5491 In distribution
10-5616 In distribution
10-5610 In distribution
11-5508 Length 13 mm In distribution
11-5599 Width 14 mm In distribution
10-9046 In distribution
10-5654 In distribution
10-9019 In distribution
10-5648 In distribution
11-5565 Width 14 mm In distribution
10-5603 In distribution
10-5606 In distribution
11-5569 Width 14 mm In distribution
11-5548 Width 14 mm In distribution
21-8970 Height 7 mm In distribution
21-9010 Height 6 mm In distribution
11-5572 Length 13 mm In distribution
11-5509 Width 14 mm In distribution
10-9030 In distribution
10-9028 In distribution
10-5613 In distribution
11-5543 Width 14 mm In distribution
10-5618 In distribution
21-9020 Height 8 mm In distribution
21-8939 Height 8 mm In distribution
10-5625 In distribution
10-5626 In distribution
11-5520 Length 13 mm In distribution
10-9044 In distribution
10-5609 In distribution
11-5573 Width 14 mm In distribution
10-9040 In distribution
11-5577 Width 14 mm In distribution
21-9022 Height 10 mm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
IdentiTi Alphatec Spine, Inc. 630
Dolomite Astura Medical 607
CoRoent Nuvasive, Inc. 580
Aeon-C Diomedical Co., Ltd. 508
Tomcat™ Cervical Spinal System Choice Spine, LP 468
Shoreline ACS Seaspine Orthopedics Corporation 428
Zavation Zavation 423
Alta™ Stand-Alone Interbody Fusion System Biomet Spine 404
Unison™-C Anterior Cervical Fixation System Pioneer Surgical Technology, Inc. 334
Chesapeake® Stabilization System VB Spine LLC 272
UniSpace® Stand-Alone C Cage CG MedTech Co., Ltd. 260
Solitaire-C Cervical Spacer Biomet Spine 256

Showing 12 of 391. All products under Intervertebral Fusion Device With Integrated Fixation, Cervical

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K173175 2017-11-01
K162760 2017-02-16

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