Quantum
GUDID 90810005669057
4.25mm dia.12mm long fixed screw Implant. The Quantum 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| Primary Device ID | 90810005669057 |
| NIH Device Record Key | c93edc93-8fdb-4266-9c4b-0c8d58af1789 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Quantum |
| Version Model Number | PCP-425-12F |
| Company DUNS | 047486041 |
| Company Name | NVISION BIOMEDICAL TECHNOLOGIES, INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Outer Diameter | 4.25 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4.25 Millimeter |
| Length | 12 Millimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *when case is full, cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *when case is full, cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *when case is full, cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *when case is full, cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *when case is full, cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *when case is full, cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *when case is full, cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *when case is full, cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *when case is full, cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *when case is full, cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *when case is full, cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *when case is full, cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *when case is full, cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *when case is full, cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *when case is full, cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *when case is full, cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *when case is full, cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *when case is full, cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *when case is full, cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *when case is full, cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *when case is full, cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *when case is full, cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *when case is full, cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *when case is full, cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *when case is full, cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *when case is full, cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *when case is full, cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *when case is full, cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *when case is full, cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *when case is full, cases should not be stacked at any time |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 90810005669057 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K210424
FDA Product Code
| KWQ | Appliance, Fixation, Spinal Intervertebral Body |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[90810005669057]
Moist Heat or Steam Sterilization
[90810005669057]
Moist Heat or Steam Sterilization
[90810005669057]
Moist Heat or Steam Sterilization
[90810005669057]
Moist Heat or Steam Sterilization
[90810005669057]
Moist Heat or Steam Sterilization
[90810005669057]
Moist Heat or Steam Sterilization
[90810005669057]
Moist Heat or Steam Sterilization
[90810005669057]
Moist Heat or Steam Sterilization
[90810005669057]
Moist Heat or Steam Sterilization
[90810005669057]
Moist Heat or Steam Sterilization
[90810005669057]
Moist Heat or Steam Sterilization
[90810005669057]
Moist Heat or Steam Sterilization
[90810005669057]
Moist Heat or Steam Sterilization
[90810005669057]
Moist Heat or Steam Sterilization
[90810005669057]
Moist Heat or Steam Sterilization
[90810005669057]
Moist Heat or Steam Sterilization
[90810005669057]
Moist Heat or Steam Sterilization
[90810005669057]
Moist Heat or Steam Sterilization
[90810005669057]
Moist Heat or Steam Sterilization
[90810005669057]
Moist Heat or Steam Sterilization
[90810005669057]
Moist Heat or Steam Sterilization
[90810005669057]
Moist Heat or Steam Sterilization
[90810005669057]
Moist Heat or Steam Sterilization
[90810005669057]
Moist Heat or Steam Sterilization
[90810005669057]
Moist Heat or Steam Sterilization
[90810005669057]
Moist Heat or Steam Sterilization
[90810005669057]
Moist Heat or Steam Sterilization
[90810005669057]
Moist Heat or Steam Sterilization
[90810005669057]
Moist Heat or Steam Sterilization
[90810005669057]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-02-09 |
| Device Publish Date | 2023-02-01 |
On-Brand Devices [Quantum]
| 90810005669170 | 4.25mm dia.12mm long variable screw Implant. The Quantum Anterior Cervical Plate is intended fo |
| 90810005669125 | 3.75mm dia.14mm long variable screw Implant. The Quantum Anterior Cervical Plate is intended fo |
| 90810005669064 | 4.25mm dia.14mm long fixed screw Implant. The Quantum Anterior Cervical Plate is intended for a |
| 90810005669057 | 4.25mm dia.12mm long fixed screw Implant. The Quantum Anterior Cervical Plate is intended for a |
Trademark Results [Quantum]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 QUANTUM 98867628 not registered Live/Pending |
Xplorian LLC 2024-11-22 |
 QUANTUM 98807712 not registered Live/Pending |
Into-Me-Sea LLC 2024-10-17 |
 QUANTUM 98804816 not registered Live/Pending |
QuantumADR LLC 2024-10-16 |
 QUANTUM 98719255 not registered Live/Pending |
Evolve Biologix Inc. 2024-08-27 |
 QUANTUM 98705080 not registered Live/Pending |
Intervet Inc. 2024-08-19 |
 QUANTUM 98650676 not registered Live/Pending |
Raynor Marketing Ltd. 2024-07-16 |
 QUANTUM 98424129 not registered Live/Pending |
HOUSE X AMERICA LLC 2024-02-27 |
 QUANTUM 98417725 not registered Live/Pending |
Meta Materials Inc. 2024-02-23 |
 QUANTUM 98388177 not registered Live/Pending |
Thomas P. Dakich 2024-02-02 |
 QUANTUM 98386723 not registered Live/Pending |
Kuku, Jalil 2024-02-01 |
 QUANTUM 98384415 not registered Live/Pending |
Starkey Laboratories, Inc. 2024-01-31 |
 QUANTUM 98362353 not registered Live/Pending |
The Upper Deck Company 2024-01-17 |
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