| Primary Device ID | 00843210121864 |
| NIH Device Record Key | 145c8d6a-99fb-40c9-bc1d-cb1d33e48e43 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Monza Cervical Plate System |
| Version Model Number | 100-1022 |
| Company DUNS | 078331322 |
| Company Name | Altus Spine, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | +1(610)355-4156 |
| Info@altus-spine.com | |
| Phone | +1(610)355-4156 |
| Info@altus-spine.com | |
| Phone | +1(610)355-4156 |
| Info@altus-spine.com | |
| Phone | +1(610)355-4156 |
| Info@altus-spine.com | |
| Phone | +1(610)355-4156 |
| Info@altus-spine.com | |
| Phone | +1(610)355-4156 |
| Info@altus-spine.com | |
| Phone | +1(610)355-4156 |
| Info@altus-spine.com | |
| Phone | +1(610)355-4156 |
| Info@altus-spine.com | |
| Phone | +1(610)355-4156 |
| Info@altus-spine.com | |
| Phone | +1(610)355-4156 |
| Info@altus-spine.com | |
| Phone | +1(610)355-4156 |
| Info@altus-spine.com | |
| Phone | +1(610)355-4156 |
| Info@altus-spine.com | |
| Phone | +1(610)355-4156 |
| Info@altus-spine.com | |
| Phone | +1(610)355-4156 |
| Info@altus-spine.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00843210121864 [Primary] |
| KWQ | Appliance, fixation, spinal intervertebral body |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00843210121864]
Moist Heat or Steam Sterilization
[00843210121864]
Moist Heat or Steam Sterilization
[00843210121864]
Moist Heat or Steam Sterilization
[00843210121864]
Moist Heat or Steam Sterilization
[00843210121864]
Moist Heat or Steam Sterilization
[00843210121864]
Moist Heat or Steam Sterilization
[00843210121864]
Moist Heat or Steam Sterilization
[00843210121864]
Moist Heat or Steam Sterilization
[00843210121864]
Moist Heat or Steam Sterilization
[00843210121864]
Moist Heat or Steam Sterilization
[00843210121864]
Moist Heat or Steam Sterilization
[00843210121864]
Moist Heat or Steam Sterilization
[00843210121864]
Moist Heat or Steam Sterilization
[00843210121864]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-11-06 |
| Device Publish Date | 2018-10-06 |
| 00843210133263 | 3&4 Level Plate Basket Bottom, Monza |
| 00843210133195 | SCP: Fixation Pin |
| 00843210121864 | SSP: Screw Driver |
| B41713543221 | Rigid Self-Tapping Screw, 4.35mm x 22mm |
| B41713543201 | Rigid Self-Tapping Screw, 4.35mm x 20mm |
| B41713543181 | Rigid Self-Tapping Screw, 4.35mm x 18mm |
| B41713543161 | Rigid Self-Tapping Screw, 4.35mm x 16mm |
| B41713543141 | Rigid Self-Tapping Screw, 4.35mm x 14mm |
| B41713543121 | Rigid Self-Tapping Screw, 4.35mm x 12mm |
| B41713540221 | Rigid Self-Tapping Screw, 4.00mm x 22mm |
| B41713540201 | Rigid Self-Tapping Screw, 4.00mm x 20mm |
| B41713540181 | Rigid Self-Tapping Screw, 4.00mm x 18mm |
| B41713540161 | Rigid Self-Tapping Screw, 4.00mm x 16mm |
| B41713540151 | Rigid Self-Tapping Screw, 4.00mm x 15mm |
| B41713540141 | Rigid Self-Tapping Screw, 4.00mm x 14mm |
| B41713540131 | Rigid Self-Tapping Screw, 4.00mm x 13mm |
| B41713540121 | Rigid Self-Tapping Screw, 4.00mm x 12mm |
| B41712043181 | Self-Tapping Screw, 4.35mm x 18mm |
| B41712043161 | Self-Tapping Screw, 4.35mm x 16mm |
| B41712043141 | Self-Tapping Screw, 4.35mm x 14mm |
| B41712043121 | Self-Tapping Screw, 4.35mm x 12mm |
| B41712040181 | Self-Tapping Screw, 4.0mm x 18mm |
| B41712040161 | Self-Tapping Screw, 4.0mm x 16mm |
| B41712040141 | Self-Tapping Screw, 4.0mm x 14mm |
| B41712040121 | Self-Tapping Screw, 4.0mm x 12mm |
| B41711604891 | 89mm Cervical Plate, 4 Level |
| B41711604861 | 86mm Cervical Plate, 4 Level |
| B41711604831 | 83mm Cervical Plate, 4 Level |
| B41711604801 | 80mm Cervical Plate, 4 Level |
| B41711604771 | 77mm Cervical Plate, 4 Level |
| B41711604741 | 74mm Cervical Plate, 4 Level |
| B41711603771 | 77mm Cervical Plate, 3 Level |
| B41711603741 | 74mm Cervical Plate, 3 Level |
| B41711603711 | 71mm Cervical Plate, 3 Level |
| B41711603681 | 68mm Cervical Plate, 3 Level |
| B41711603651 | 65mm Cervical Plate, 3 Level |
| B41711603621 | 62mm Cervical Plate, 3 Level |
| B41711603591 | 59mm Cervical Plate, 3 Level |
| B41711603561 | 56mm Cervical Plate, 3 Level |
| B41711603531 | 53mm Cervical Plate, 3 Level |
| B41711603501 | 50mm Cervical Plate, 3 Level |
| B41711602561 | 56mm Cervical Plate, 2 Level |
| B41711602531 | 53mm Cervical Plate, 2 Level |
| B41711602501 | 50mm Cervical Plate, 2 Level |
| B41711602471 | 47mm Cervical Plate, 2 Level |
| B41711602441 | 44mm Cervical Plate, 2 Level |
| B41711602411 | 41mm Cervical Plate, 2 Level |
| B41711602381 | 38mm Cervical Plate, 2 Level |
| B41711602351 | 35mm Cervical Plate, 2 Level |
| B41711601361 | 36mm Cervical Plate, 1 Level |