tangis ACP-3-62

GUDID 90814008023403

Anterior Cervical Plating System, 3 level implant. The Tangis Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudarthrosis, • failed previous fusion, • spinal stenosis

NVISION BIOMEDICAL TECHNOLOGIES, INC.

Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system
Primary Device ID90814008023403
NIH Device Record Key9998476f-19af-4a02-a5fe-345cd89c394b
Commercial Distribution StatusIn Commercial Distribution
Brand Nametangis
Version Model NumberACP-3-62
Catalog NumberACP-3-62
Company DUNS047486041
Company NameNVISION BIOMEDICAL TECHNOLOGIES, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com

Device Dimensions

Depth1.98 Millimeter
Depth1.98 Millimeter
Depth1.98 Millimeter
Depth1.98 Millimeter
Depth1.98 Millimeter
Depth1.98 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS190814008023403 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[90814008023403]

Moist Heat or Steam Sterilization

[90814008023403]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2020-01-20
Device Publish Date2017-02-28

On-Brand Devices [tangis]

00814008025657Instrument, Drill 20mm, Anterior Cervical Plating System (ACP)
00814008025640Instrument, Drill 18mm, Anterior Cervical Plating System (ACP)
00814008025633Instrument, Drill 16mm, Anterior Cervical Plating System (ACP)
00814008025626Instrument, Drill 14mm, Anterior Cervical Plating System (ACP)
00814008025619Instrument, Drill 12mm, Anterior Cervical Plating System (ACP)
00814008025602Instrument, 10mm Drill, Anterior Cervical Plating System (ACP)
00814008025596Instrument, Drill, Anterior Cervical Plating System (ACP) for 4.25mm diameter screw.
00814008024087Instrument, Plate Holder, Anterior Cervical Plating System (ACP)
00814008024070Instrument, Plate Bender, Anterior Cervical Plating System (ACP)
00814008024063Instrument, Handle with Spin Cap, Anterior Cervical Plating System (ACP)
00814008024056Instrument, Punch Awl, Anterior Cervical Plating System (ACP)
00814008024049Instrument, Lock Engagement Tool, Anterior Cervical Plating System (ACP)
00814008024032Instrument, Screw Inserter, Anterior Cervical Plating System (ACP)
00814008024025Instrument, Cannulated Driver, Anterior Cervical Plating System (ACP)
00814008024018Instrument, Single Drill Guide, Variable, Anterior Cervical Plating System (ACP)
00814008024001Instrument, Single Drill Guide, Fixed, Anterior Cervical Plating System (ACP)
00814008023998Instrument, Double Drill Guide, Anterior Cervical Plating System (ACP)
00814008023981Instrument, Fixation Pin, Push, Anterior Cervical Plating System (ACP)
00814008023974Instrument, Fixation Pin, Threaded, Anterior Cervical Plating System (ACP)
00814008023967Instrument, Tap, Anterior Cervical Plating System (ACP)
00814008023950Instrument, Drill, Anterior Cervical Plating System (ACP)
00814008023943Instrument, Awl, Anterior Cervical Plating System (ACP)
00814008023936Instrument, Caddy Body 4 Level Plate, Anterior Cervical Plating System (ACP)
00814008023929Instrument, Caddy Lid Screws, Anterior Cervical Plating System (ACP)
00814008023912Instrument, Caddy Body 1-3 Level Plate, Anterior Cervical Plating System (ACP)
00814008023905Instrument, Caddy Body for Screws, Anterior Cervical Plating System (ACP)
00814008023899Instrument, Caddy Lid 1-3 Level Plates, Anterior Cervical Plating System (ACP)
00814008023882Instrument, Caddy Lid 4 Level Plates, Anterior Cervical Plating System (ACP)
00814008023875Instrument, Tray Insert 1, Anterior Cervical Plating System (ACP)
00814008023868Instrument Tray-Lid, Anterior Cervical Plating System (ACP)
00814008023851Instrument Tray-Base, Anterior Cervical Plating System (ACP)
90814008023847Anterior Cervical Plating System, 4.25mm dia. 20mm long variable screw. The Tangis Anterior Cer
90814008023830Anterior Cervical Plating System, 4.75mm dia. 20mm long variable screw
90814008023823Anterior Cervical Plating System, 4.75mm dia. 18mm long variable screw
90814008023816Anterior Cervical Plating System, 4.75mm dia. 16mm long variable screw
90814008023809Anterior Cervical Plating System, 4.75mm dia. 14mm long variable screw. The Tangis Anterior Cer
90814008023793Anterior Cervical Plating System, 4.75mm dia. 12mm long variable screw
90814008023786Anterior Cervical Plating System, 4.75mm dia. 10mm long variable screw
90814008023779Anterior Cervical Plating System, 4.25mm dia. 18mm long variable screw
90814008023762Anterior Cervical Plating System, 4.25mm dia. 16mm long variable screw
90814008023755Anterior Cervical Plating System, 4.25mm dia. 14mm long variable screw
90814008023748Anterior Cervical Plating System, 4.25mm dia. 12mm long variable screw. The Tangis Anterior Cer
90814008023731Anterior Cervical Plating System, 4.25mm dia. 10mm long variable scew
90814008023724Anterior Cervical Plating System, 3.75mm dia. 20mm long variable screw
90814008023717Anterior Cervical Plating System, 3.75mm dia. 18mm long variable screw
90814008023700Anterior Cervical Plating System, 3.75mm dia. 16mm long variable screw
90814008023694Anterior Cervical Plating System, 3.75mm dia. 14mm long variable screw
90814008023687Anterior Cervical Plating System, 3.75mm dia. 12mm long variable screw
90814008023670Anterior Cervical Plating System, 3.75mm dia. 10mm long variable screw
90814008023663Anterior Cervical Plating System, 4.25mm dia. 20mm long fixed screw

Trademark Results [tangis]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TANGIS
TANGIS
90228120 not registered Live/Pending
Wang JieFu
2020-09-30
TANGIS
TANGIS
86965846 5178041 Live/Registered
NVision BioMedical Technologies, LLC
2016-04-06
TANGIS
TANGIS
75982098 2598787 Dead/Cancelled
XD Inc.
1998-11-13
TANGIS
TANGIS
75588244 not registered Dead/Abandoned
TANGIS CORPORATION
1998-11-13
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