tangis
- Primary DI
- 90814008023298
- Brand
- tangis
- Company
- NVISION BIOMEDICAL TECHNOLOGIES, INC.
- Model
- ACP-2-33
- Catalog number
- ACP-2-33
- Device description
- Anterior Cervical Plating System, 2 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
- Single use
- true
Contact Domains#
Product Codes#
| Code | Name |
|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K161524 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 90814008023298 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 90814008023298 | 90814008023298 |
GMDN Terms#
| Term | Definition |
|---|---|
| Intervertebral-body internal spinal fixation system | A group of sterile implantable devices designed to apply force to a series of vertebrae to correct scoliosis (lateral curvature of the spine) or other spinal conditions. The system components are typically made of medical grade titanium and consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the centre of each plate, and a braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and is fastened or crimped at each eye-type screw. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Depth | 1.98 | Millimeter |
| Height | 33 | Millimeter |
| Width | 17 | Millimeter |
Sterilization Methods#
| Method |
|---|
| Moist Heat or Steam Sterilization |
Contacts#
| Phone | |
|---|---|
| 210-545-3713 | diana@nvisionbiomed.com |
Regulatory Flags#
- DUNS number
- 047486041
- Device count
- 1
- DM exempt
- true
- Lot or batch
- true
- Sterilization required before use
- true
Other Devices From This Company#
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|---|---|---|---|---|
| 00810005668088 | Trigon | WD-1001C-700 | 2026-04-24 | |
| 00810005668095 | Trigon | MTP-22-08-00 | 2026-04-24 | |
| 00810005668101 | Trigon | MTP-22-10-00 | 2026-04-24 | |
| 00810005668118 | Trigon | MTP-22-12-00 | 2026-04-24 | |
| 00810005668125 | Trigon | WD-1000T-MWIS | 2026-04-24 | |
| 00810005668187 | Trigon | MTP-18-08-00 | 2026-04-24 | |
| 00810135963565 | Trigon | MTP-18-10-00 | 2026-04-24 | |
| 00810135963572 | Trigon | MTP-18-12-00 | 2026-04-24 | |
| 00810005668132 | Trigon | MTP-22-08T-00 | 2026-04-23 | |
| 00810005668149 | Trigon | MTP-22-10T-00 | 2026-04-23 | |
| 00810005668156 | Trigon | MTP-22-12T-00 | 2026-04-23 | |
| 00810135963589 | Trigon | MTP-18-08T-00 | 2026-04-23 | |
| 00810135963596 | Trigon | MTP-18-10T-00 | 2026-04-23 | |
| 00810135963602 | Trigon | MTP-18-12T-00 | 2026-04-23 | |
| 00810135960502 | Retropsoas Electrode | ELEC1000-04 | 2023-10-25 | |
| 00810135960519 | Retropsoas Electrode | ELEC1000-06 | 2023-10-25 | |
| 00810135960526 | Retropsoas Electrode | ELEC1000-08 | 2023-10-25 | |
| 00810135960533 | Retropsoas Electrode | ELEC1000-10 | 2023-10-25 | |
| 00810135960540 | Retropsoas Electrode | ELEC2100 | 2023-10-25 | |
| 00810135960557 | Retropsoas Electrode | ELEC2240 | 2023-10-25 |
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| 08809986492807 | CastleLoc-P Anterior Cervical Plate System | L&K BIOMED CO. ,LTD. | KWQ | 2026-06-09 |
| 08809986492814 | CastleLoc-P Anterior Cervical Plate System | L&K BIOMED CO. ,LTD. | KWQ | 2026-06-09 |
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