Mecta-C Cervical Ti-Peek Cages

Mecta-C Cervical TiPEEK Cages support anterior cervical interbody fusion in skeletally mature patients with cervical disc disease. They are intended for one treated level from C2 to T1,…

Registry build 21.09.26

Mecta-C Cervical TiPEEK Cages support anterior cervical interbody fusion in skeletally mature patients with cervical disc disease. They are intended for one treated level from C2 to T1, following at least six weeks of nonoperative treatment and confirmation of degeneration by history and imaging.

Each cage has a PEEK body with a commercially pure titanium coating. Tantalum markers at the ends help assess the position and orientation of the radiolucent implant on imaging. Its hollow center accommodates the patient’s own bone graft.

Listed Item

Cervical Interbody Fusion Device Dome Shaped 15x18x6 L5°

Graft and Fixation

The implant requires autogenous bone graft and supplemental spinal fixation. One cage is used per intervertebral space. Different widths, heights, footprints and lordotic configurations accommodate the prepared cervical disc space.

7manufacturers in China registered for this device type
60catalogue numbers in this listing
2510(k) clearances naming this product code

Who Else Makes It

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

Chinese manufacturers registered for FDA product code ODP
Manufacturer City Province Registered as Device types
Shandong Weigao Orthopaedic Device Co., Ltd. Weihai Shandong Contract manufacturer 42
Zibo Dante Co., Ltd. Zibo Shandong Contract manufacturer 17
Zhisu Health Tech Jiaxing Co., Ltd. Tongxiang Zhejiang Contract manufacturer 4
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai Shanghai Exporter 106
Medtronic (Changzhou) Medical Devices Technology Co., Ltd. Changzhou Jiangsu Manufacturer 53
Zhejiang Decans Medical Devices Co., Ltd. Jiaxing Zhejiang Manufacturer 10
Shanghai Sanyou Medical Co., Ltd. Shanghai Shanghai Manufacturer 6

Record

Regulatory record for Mecta-C Cervical Ti-Peek Cages
Listed by Medacta International SA, Switzerland
FDA product code ODP
Device type Intervertebral Fusion Device With Bone Graft, Cervical
Device class Class 2
Regulation 21 CFR 888.3080
Establishment Specification developer, Repacker / relabeller, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter
510(k) K142744
Record published 2015-09-21
Record revised 2025-07-14 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for Mecta-C Cervical Ti-Peek Cages
Catalogue number Size Status
03.28.727 In distribution
03.28.720 In distribution
03.28.705 In distribution
03.28.625 In distribution
03.28.706 In distribution
03.28.708 In distribution
03.28.630 In distribution
03.28.627 In distribution
03.28.723 In distribution
03.28.709 In distribution
03.28.726 In distribution
03.28.716 In distribution
03.28.613 In distribution
03.28.711 In distribution
03.28.618 In distribution
03.28.602 In distribution
03.28.601 In distribution
03.28.728 In distribution
03.28.608 In distribution
03.28.712 In distribution
03.28.701 In distribution
03.28.704 In distribution
03.28.603 In distribution
03.28.622 In distribution
03.28.722 In distribution
03.28.710 In distribution
03.28.619 In distribution
03.28.707 In distribution
03.28.609 In distribution
03.28.607 In distribution
03.28.614 In distribution
03.28.717 In distribution
03.28.719 In distribution
03.28.718 In distribution
03.28.621 In distribution
03.28.604 In distribution
03.28.702 In distribution
03.28.730 In distribution
03.28.620 In distribution
03.28.713 In distribution
03.28.624 In distribution
03.28.715 In distribution
03.28.629 In distribution
03.28.703 In distribution
03.28.610 In distribution
03.28.628 In distribution
03.28.721 In distribution
03.28.605 In distribution
03.28.626 In distribution
03.28.729 In distribution
03.28.714 In distribution
03.28.623 In distribution
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03.28.616 In distribution
03.28.615 In distribution
03.28.725 In distribution
03.28.612 In distribution
03.28.606 In distribution
03.28.617 In distribution
03.28.611 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Latitude-C AM™ Cervical Interbody Fusion System Degen Medical 1,529
IdentiTi Alphatec Spine, Inc. 1,390
Zavation Zavation 1,357
IVA Cage Ti Diomedical Co., Ltd. 1,202
Latitude-C Cervical Interbody Spacer System Degen Medical 1,185
Peridot Anterior Cervical Intervertebral Body Fusion System Gbs Commonwealth Co., Ltd. 1,056
Aleutian® Interbody Systems VB Spine LLC 1,017
Valeo Spacer System Sintx Technologies Inc. 918
Cascadia™ Interbody System VB Spine LLC 823
CoRoent Nuvasive, Inc. 815
Tyber Medical Tyber Medical 740
Matisse Anterior Cervical Interbody Fusion Cage System CTL Medical Corporation 577

Showing 12 of 938. All products under Intervertebral Fusion Device With Bone Graft, Cervical

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K142744 2015-05-07
K112862 2011-12-19

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