tangis

Primary DI
90814008023403
Brand
tangis
Company
NVision Biomedical Technologies, Inc.
Model
ACP-3-62
Catalog number
ACP-3-62
Device description
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
Published
2017-02-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161524000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161524000Tangis Anterior Cervical PlateNvision Biomedical Technologies, LLC2016-09-02KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
90814008023403PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
9081400802340390814008023403

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization as part of treatment of a spinal instability or deformity; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth0
Height0
Width0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
210-545-3713diana@nvisionbiomed.com

Regulatory Flags#

DUNS number
047486041
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810005666855TrigonLD-050004T-282024-02-22
00810005666862TrigonLD-050006T-282024-02-22
00810005666985TrigonLDP-2408-04102024-02-22
00810005666992TrigonLDP-2408-04082024-02-22
00810005667005TrigonLDP-2408-04062024-02-22
00810005667012TrigonLDP-2408-04042024-02-22
00810005667029TrigonLDP-2408-02102024-02-22
00810005667036TrigonLDP-2408-02082024-02-22
00810005667043TrigonLDP-2408-02062024-02-22
00810005667050TrigonLDP-2408-02042024-02-22
00810005667067TrigonLDP-2408-00102024-02-22
00810005667074TrigonLDP-2408-00082024-02-22
00810005667081TrigonLDP-2408-00062024-02-22
00810005667098TrigonLDP-2408-00042024-02-22
00810005667104TrigonLDP-2405-04082024-02-22
00810005667111TrigonLDP-2405-04062024-02-22
00810005667128TrigonLDP-2405-04042024-02-22
00810005667135TrigonLDP-2405-02082024-02-22
00810005667142TrigonLDP-2405-02062024-02-22
00810005667159TrigonLDP-2405-02042024-02-22

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