3d Printed Interbody Systems

Lateral Implant, 23mm x 10mm x 50mm, 10 Deg, 3D

Registry build 21.09.26
1manufacturer
62catalogue 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 3D Printed Interbody Systems
Listed by Seaspine Orthopedics Corporation, 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, Complaint-file establishment, Manufacturer
510(k) K213420
Record published 2024-04-06
Record revised 2025-10-24 (version 4)

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 3D Printed Interbody Systems
Catalogue number Size Status
WL4-144500 In distribution
WL4-224000 In distribution
WL4-205010 In distribution
WL4-244000 In distribution
WL4-244010 In distribution
WL4-165515 In distribution
WL4-265510 In distribution
WL4-264015 In distribution
WL4-105000 In distribution
WL4-204000 In distribution
WL4-106010 In distribution
WL4-284510 In distribution
WL4-266015 In distribution
WL4-145010 In distribution
WL4-184510 In distribution
WL4-145015 In distribution
WL4-204500 In distribution
WL4-145510 In distribution
WL4-265515 In distribution
WL4-126015 In distribution
WL4-244515 In distribution
WL4-124510 In distribution
WL4-264500 In distribution
WL4-164010 In distribution
WL4-104500 In distribution
WL4-264510 In distribution
WL4-226015 In distribution
WL4-245515 In distribution
WL4-124000 In distribution
WL4-245015 In distribution
WL4-144000 In distribution
WL4-146015 In distribution
WL4-105515 In distribution
WL4-205510 In distribution
WL4-265010 In distribution
WL4-204510 In distribution
WL4-104515 In distribution
WL4-204015 In distribution
WL4-264515 In distribution
WL4-285510 In distribution
WL4-206010 In distribution
WL4-165015 In distribution
WL4-224500 In distribution
WL4-246010 In distribution
WL4-124010 In distribution
WL4-184010 In distribution
WL4-285000 In distribution
WL4-245000 In distribution
WL4-165510 In distribution
WL4-185010 In distribution
WL4-125010 In distribution
WL4-225010 In distribution
WL4-264010 In distribution
WL4-104010 In distribution
WL4-265000 In distribution
WL4-225515 In distribution
WL4-164500 In distribution
WL4-144515 In distribution
WL4-224510 In distribution
WL4-224015 In distribution
WL4-184000 In distribution
WL4-164000 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
CoRoent Nuvasive, Inc. 2,299
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

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