CoRoent

Oblique TLIF Inserter, 10x30mm Rotate QC

Registry build 21.09.26
1manufacturer
2,299catalogue numbers in this listing

Who Else Makes It

Registered in Shandong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code PHM
Manufacturer City Province Registered as Device types
Shandong Weigao Orthopaedic Device Co., Ltd. Weihai Shandong Contract manufacturer 42

Record

Regulatory record for CoRoent
Listed by Nuvasive, Inc., United States
FDA product code PHM
Device type Intervertebral Fusion Device With Bone Graft, Thoracic
Device class Class 2
Regulation 21 CFR 888.3080
Establishment Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
510(k) K170962
Record published 2018-02-06
Record revised 2025-07-14 (version 7)

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, manufacturing date

Catalogue Numbers

Catalogue numbers for CoRoent
Catalogue number Size Status
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Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
IdentiTi Alphatec Spine, Inc. 940
Solar™ Interbody Fusion System Degen Medical 805
Transcend Nanotec Alphatec Spine, Inc. 466
IDENTITi Nanotec Alphatec Spine, Inc. 459
E3D-A Interbody System Evolution Spine, LLC 308
Battalion Alphatec Spine, Inc. 241
Reef L Seaspine Orthopedics Corporation 207
IdentiTi II Alphatec Spine, Inc. 163
Modulus Nuvasive, Inc. 158
Hedron Globus Medical, Inc. 156
Roccia Silony Medical Gmbh 133
TLX Nuvasive, Inc. 88

Showing 12 of 41. All products under Intervertebral Fusion Device With Bone Graft, Thoracic

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