OMNIBotics

Self-tapping and self-drilling bone screw Ø4mm, L150mm, thread 45mm

Registry build 21.09.26
5manufacturers in China registered for this device type
150catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (2), Shanghai (1), Guangdong (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 OLO
Manufacturer City Province Registered as Device types
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Paragon Medical Device (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 53
Shandong Weigao Orthopaedic Device Co., Ltd. Weihai Shandong Contract manufacturer 42
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai Shanghai Exporter 106
Medtronic (Changzhou) Medical Devices Technology Co., Ltd. Changzhou Jiangsu Manufacturer 53

Record

Regulatory record for OMNIBotics
Listed by Omni Life Science, Inc., United States
FDA product code OLO
Device type Orthopedic Stereotaxic Instrument
Device class Class 2
Regulation 21 CFR 882.4560
Premarket notification Exempt
Record published 2023-01-10
Record revised 2023-05-03 (version 2)

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, serial number

Catalogue Numbers

Catalogue numbers for OMNIBotics
Catalogue number Size Status
NV-LPT07-US In distribution
NS-42000 In distribution
NS-5013L In distribution
NS-3000G In distribution
NS-41000 In distribution
NS-40040 In distribution
NS-06996-RH In distribution
NS-44000 In distribution
NS-S5000-IN In distribution
NS-5012L In distribution
NS-5015L In distribution
NV-CRD05 In distribution
NS-40011 In distribution
4148-1004 In distribution
NS-40150 In distribution
9-144 In distribution
NS-27011 In distribution
RM-10005 In distribution
NV-CAM02 In distribution
NS-27012 In distribution
NS-5033A In distribution
NS-06750 In distribution
4145-5100 In distribution
NS-27111 In distribution
NV-CAM01 In distribution
NS-300P4-SS In distribution
NS-27114 In distribution
KS-S1001 In distribution
NS-5036B In distribution
NS-5035B In distribution
NS-27013 In distribution
NS-300P4-TI In distribution
NS-27016 In distribution
NS-27112 In distribution
NS-5022R-A In distribution
4145-5004 In distribution
NS-40021 In distribution
NS-27015 In distribution
NS-5035A In distribution
NS-5024R-B In distribution
4146-5200 In distribution
NV-CAS02 In distribution
NS-5024R-A In distribution
NS-06996 In distribution
NS-06752 In distribution
NS-5031B In distribution
NS-5012R In distribution
NS-5011R In distribution
NS-5015R In distribution
NV-LPT04 In distribution
4145-3100 In distribution
NV-CRT01 In distribution
NV-CAS01 In distribution
NS-40300 In distribution
RM-10004 In distribution
4146-1000 In distribution
NS-27010 In distribution
NS-40052 In distribution
4145-5003 In distribution
4154-5000 In distribution
NS-5013R In distribution
NS-5022L-B In distribution
4144-4000 In distribution
4144-5000 In distribution
NS-27014 In distribution
NV-CRT07 In distribution
NV-LPT02 In distribution
4161-5400 In distribution
NS-300G4-SS In distribution
NS-27003 In distribution
4144-8000 In distribution
NS-5036A In distribution
NV-CRD02 In distribution
NS-5034B In distribution
NS-43000 In distribution
KS-S1002 In distribution
2205-2000 In distribution
NS-5031A In distribution
NV-CRT05 In distribution
2202-2000 In distribution
NV-CRD06 In distribution
0501-5070 In distribution
NV-CRD04 In distribution
NS-5014L In distribution
4148-1001 In distribution
4160-5000 In distribution
4145-1030 In distribution
NS-5032A In distribution
4146-5300 In distribution
NS-27113 In distribution
NS-40400 In distribution
NS-5016L In distribution
KS-S1002-IN In distribution
NS-27007 In distribution
NS-5033B In distribution
4137-5050 In distribution
NS-40130 In distribution
RM-10002 In distribution
NS-5011L In distribution
NS-26220 In distribution
4137-2050 In distribution
4148-1005 In distribution
NS-5024L-B In distribution
NS-5022R-B In distribution
NV-LPT05 In distribution
RM-10003 In distribution
NS-53000 In distribution
NV-CRD07 In distribution
4137-5000 In distribution
NS-5034A In distribution
NS-5016R In distribution
4154-5100 In distribution
NS-40030 In distribution
NS-40100 In distribution
NV-LPT07-OUS In distribution
TOOL 14-020 In distribution
4144-7000 In distribution
4149-5000 In distribution
4145-2000 In distribution
NS-27017 In distribution
NS-5032B In distribution
NS-S5000 In distribution
NS-40020 In distribution
NV-CRD01 In distribution
0501-5000 In distribution
NS-40053 In distribution
KS-S1001-IN In distribution
NS-5022L-A In distribution
NS-27008 In distribution
RM-10000 In distribution
0501-5030 In distribution
4148-1002 In distribution
RM-10001 In distribution
4146-5000 In distribution
0530-2000 In distribution
NV-LPT03 In distribution
NV-CRD03 In distribution
0770-2000 In distribution
0113-0000 In distribution
NS-27009 In distribution
KS-62030 In distribution
NS-5014R In distribution
NS-300T4-AL In distribution
NS-40600 In distribution
4144-6000 In distribution
NS-26120 In distribution
4148-2000 In distribution
0501-5020 In distribution
4161-5100 In distribution
NS-5024L-A In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Valence Robotic Navigation System Alphatec Spine, Inc. 813
Olympic Astura Medical 684
Excelsius GPS Globus Medical, Inc. 383
Orthopedic Stereotaxic Instrument Medtronic Navigation, Inc. 356
Masada Astura Medical 335
Excelsiusgps Globus Medical, Inc. 297
Invictus Alphatec Spine, Inc. 235
OrthAlign Plus OrthAlign, Inc. 210
Arvis ® Kico Knee Innovation Company 174
CD Horizon® Spinal System Medtronic Sofamor Danek, Inc. 137
Navigation Instruments VB Spine LLC 135
Orthopedic Stereotaxic Instrument Mako Surgical Corp. 124

Showing 12 of 1,127. All products under Orthopedic Stereotaxic Instrument

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