Orthopedic › ProstheticIntervertebral Fusion Device With Integrated Fixation, Cervical

Omnia Medical TiBrid™-SC

TiBrid™-SC Drill Guide Attachment, 16.5x14.5x07mm

Registry build 21.09.26
5manufacturers in China registered for this device type
149catalogue numbers in this listing
1510(k) clearance

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 Omnia Medical TiBrid™-SC
Listed by Omnia Medical, 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 Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k) K212612
Record published 2024-02-16
Record revised 2024-09-11 (version 3)

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 Length 8 to 18 mm; height 5 to 26 mm; width 14.5 to 16.5 mm; outer diameter 2 to 4.5 mm

Catalogue Numbers

Catalogue numbers for Omnia Medical TiBrid™-SC
Catalogue number Size Status
10-7C-RA16-08 Width 16.5 mm In distribution
10-5C-DR06 Height 6 mm In distribution
10-0C-4008-VT Outer Diameter 4 mm In distribution
10-0C-4014-FT Outer Diameter 4 mm In distribution
10-7C-TR16-09 Width 16.5 mm In distribution
10-0C-4018-FT Outer Diameter 4 mm In distribution
10-0C-4016-FT Outer Diameter 4 mm In distribution
10-5C-DR07 Height 7 mm In distribution
10-0C-4518-VD Outer Diameter 4.5 mm In distribution
10-7C-RA16-12 Width 16.5 mm In distribution
10-0C-181508 Length 18 mm In distribution
10-0C-DU24 Height 24 mm In distribution
10-5C-DRG3-1607 Length 16.5 mm In distribution
10-0C-QU24 Height 24 mm In distribution
10-5C-PGD1-16 In distribution
10-0C-4018-VT Outer Diameter 4 mm In distribution
10-0C-4512-VD Outer Diameter 4.5 mm In distribution
10-0C-DU25 Height 25 mm In distribution
10-0C-181510 Length 18 mm In distribution
10-0C-QU20 Height 20 mm In distribution
10-0C-4508-VD Outer Diameter 4.5 mm In distribution
10-5C-TR16-10 Width 16.5 mm In distribution
10-0C-4510-FD Outer Diameter 4.5 mm In distribution
10-7C-TR16-10 Width 16.5 mm In distribution
10-0C-4510-VT Outer Diameter 4.5 mm In distribution
10-5C-TR16-08 Width 16.5 mm In distribution
10-0C-4012-VD Outer Diameter 4 mm In distribution
10-0C-DU26 Height 26 mm In distribution
10-0C-4514-VT Outer Diameter 4.5 mm In distribution
10-5C-RA16-07 Width 16.5 mm In distribution
10-5C-DRL1 Outer Diameter 2 mm In distribution
10-0C-161409 Length 16.5 mm In distribution
10-0C-161410 Length 16.5 mm In distribution
10-0C-4018-FD Outer Diameter 4 mm In distribution
10-0C-4016-FD Outer Diameter 4 mm In distribution
10-0C-4012-VT Outer Diameter 4 mm In distribution
10-0C-TR22 Height 22 mm In distribution
10-5C-DRV1 In distribution
10-0C-4008-VD Outer Diameter 4 mm In distribution
10-5C-RA16-11 Width 16.5 mm In distribution
10-7C-RA16-07 Width 16.5 mm In distribution
10-0C-QU26 Height 26 mm In distribution
10-0C-QU22 Height 22 mm In distribution
10-0C-4512-FT Outer Diameter 4.5 mm In distribution
10-0C-4508-FT Outer Diameter 4.5 mm In distribution
10-0C-TR20 Height 20 mm In distribution
10-5C-DR09 Height 9 mm In distribution
10-0C-4510-VD Outer Diameter 4.5 mm In distribution
10-5C-DRG3-1811 Length 18 mm In distribution
10-0C-4516-FD Outer Diameter 4.5 mm In distribution
10-0C-TR26 Height 26 mm In distribution
10-0C-4018-VD Outer Diameter 4 mm In distribution
10-5C-DRG3-1609 Length 16.5 mm In distribution
10-5C-DR16 Height 16 mm In distribution
10-5C-AWL2 In distribution
10-0C-4010-FT Outer Diameter 4 mm In distribution
10-5C-IMP1 In distribution
10-0C-DU20 Height 20 mm In distribution
10-7C-TR16-11 Width 16.5 mm In distribution
10-5C-DRG3-1810 Length 18 mm In distribution
10-0C-4514-FD Outer Diameter 4.5 mm In distribution
10-5C-DRG3-1606 Length 16.5 mm In distribution
10-5C-DR08 Height 8 mm In distribution
10-5C-DRG3-1809 Length 18 mm In distribution
10-5C-DRG3-1610 Length 16.5 mm In distribution
10-7C-TR16-06 Width 16.5 mm In distribution
10-0C-QU23 Height 23 mm In distribution
10-0C-181507 Length 18 mm In distribution
10-5C-DRG2 In distribution
10-5C-DR10 Height 10 mm In distribution
10-0C-161408 Length 16.5 mm In distribution
10-5C-DR05 Height 5 mm In distribution
10-0C-181506 Length 18 mm In distribution
10-0C-4518-FD Outer Diameter 4.5 mm In distribution
10-0C-161407 Length 16.5 mm In distribution
10-7C-RA16-09 Width 16.5 mm In distribution
10-5C-DRG3-1611 Length 16.5 mm In distribution
10-5C-RA16-06 Width 16.5 mm In distribution
10-5C-TR16-11 Width 16.5 mm In distribution
10-0C-4016-VT Outer Diameter 4 mm In distribution
10-5C-DRG3-1812 Length 18 mm In distribution
10-5C-INS1 In distribution
10-5C-DRG3-1608 Length 16.5 mm In distribution
10-0C-4008-FD Outer Diameter 4 mm In distribution
10-0C-TR23 Height 23 mm In distribution
10-0C-4012-FD Outer Diameter 4 mm In distribution
10-5C-PGD1-18 In distribution
10-0C-4014-FD Outer Diameter 4 mm In distribution
10-5C-DRL2 Outer Diameter 2.5 mm In distribution
10-5C-TR16-07 Width 16.5 mm In distribution
10-0C-QU21 Height 21 mm In distribution
10-0C-4010-FD Outer Diameter 4 mm In distribution
10-5C-RA16-12 Width 16.5 mm In distribution
10-0C-4518-FT Outer Diameter 4.5 mm In distribution
10-7C-TR16-08 Width 16.5 mm In distribution
10-0C-DU21 Height 21 mm In distribution
10-0C-181511 Length 18 mm In distribution
10-0C-4508-VT Outer Diameter 4.5 mm In distribution
10-0C-181509 Length 18 mm In distribution
10-0C-4514-VD Outer Diameter 4.5 mm In distribution
10-0C-SCVR In distribution
10-5C-DR11 Height 11 mm In distribution
10-0C-DU22 Height 22 mm In distribution
10-0C-4516-VD Outer Diameter 4.5 mm In distribution
10-7C-RA16-11 Width 16.5 mm In distribution
10-5C-RA16-09 Width 16.5 mm In distribution
10-0C-4012-FT Outer Diameter 4 mm In distribution
10-5C-TR16-09 Width 16.5 mm In distribution
10-0C-TR25 Height 25 mm In distribution
10-5C-RA16-08 Width 16.5 mm In distribution
10-0C-4008-FT Outer Diameter 4 mm In distribution
10-0C-4010-VD Outer Diameter 4 mm In distribution
10-0C-4512-VT Outer Diameter 4.5 mm In distribution
10-0C-4516-FT Outer Diameter 4.5 mm In distribution
10-0C-DU23 Height 23 mm In distribution
10-0C-161411 Length 16.5 mm In distribution
10-5C-DRG3-1806 Length 18 mm In distribution
10-5C-TR16-12 Width 16.5 mm In distribution
10-5C-DR12 Height 12 mm In distribution
10-0C-4016-VD Outer Diameter 4 mm In distribution
10-0C-181512 Length 18 mm In distribution
10-5C-AWL1 In distribution
10-5C-DRV2 In distribution
10-0C-4518-VT Outer Diameter 4.5 mm In distribution
10-0C-4516-VT Outer Diameter 4.5 mm In distribution
10-5C-DR14 Height 14 mm In distribution
10-0C-QU25 Height 25 mm In distribution
10-7C-RA16-10 Width 16.5 mm In distribution
10-5C-RMV1 In distribution
10-0C-TR21 Height 21 mm In distribution
10-0C-4014-VD Outer Diameter 4 mm In distribution
10-7C-TR16-12 Width 16.5 mm In distribution
10-5C-DRG3-1808 Length 18 mm In distribution
10-7C-TR16-07 Width 16.5 mm In distribution
10-5C-DRG3-1612 Length 16.5 mm In distribution
10-0C-4014-VT Outer Diameter 4 mm In distribution
10-0C-4510-FT Outer Diameter 4.5 mm In distribution
10-0C-4514-FT Outer Diameter 4.5 mm In distribution
10-0C-161406 Length 16.5 mm In distribution
10-0C-161412 Length 16.5 mm In distribution
10-5C-DRG3-1807 Length 18 mm In distribution
10-0C-4508-FD Outer Diameter 4.5 mm In distribution
10-5C-DR18 Height 18 mm In distribution
10-5C-RA16-10 Width 16.5 mm In distribution
10-5C-TR16-06 Width 16.5 mm In distribution
10-0C-TR24 Height 24 mm In distribution
10-0C-4512-FD Outer Diameter 4.5 mm In distribution
10-0C-4010-VT Outer Diameter 4 mm In distribution
10-7C-RA16-06 Width 16.5 mm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
IdentiTi Alphatec Spine, Inc. 630
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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
K212612 2022-11-15

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