| Primary Device ID | B030ORT5535C0 |
| NIH Device Record Key | dbdf3e92-34bc-46a2-8d3b-8c479a425482 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Orthors |
| Version Model Number | ORT-5535C |
| Company DUNS | 054205979 |
| Company Name | CAMBER SPINE TECHNOLOGIES, LLC |
| Device Count | 1 |
| DM Exempt | false |
| 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 | true |
| 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 |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B030ORT5535C0 [Primary] |
| NKB | Thoracolumbosacral Pedicle Screw System |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B030ORT5535C0]
Moist Heat or Steam Sterilization
[B030ORT5535C0]
Moist Heat or Steam Sterilization
[B030ORT5535C0]
Moist Heat or Steam Sterilization
[B030ORT5535C0]
Moist Heat or Steam Sterilization
[B030ORT5535C0]
Moist Heat or Steam Sterilization
[B030ORT5535C0]
Moist Heat or Steam Sterilization
[B030ORT5535C0]
Moist Heat or Steam Sterilization
[B030ORT5535C0]
Moist Heat or Steam Sterilization
[B030ORT5535C0]
Moist Heat or Steam Sterilization
[B030ORT5535C0]
Moist Heat or Steam Sterilization
[B030ORT5535C0]
Moist Heat or Steam Sterilization
[B030ORT5535C0]
Moist Heat or Steam Sterilization
[B030ORT5535C0]
Moist Heat or Steam Sterilization
[B030ORT5535C0]
Moist Heat or Steam Sterilization
[B030ORT5535C0]
Moist Heat or Steam Sterilization
[B030ORT5535C0]
Moist Heat or Steam Sterilization
[B030ORT5535C0]
Moist Heat or Steam Sterilization
[B030ORT5535C0]
Moist Heat or Steam Sterilization
[B030ORT5535C0]
Moist Heat or Steam Sterilization
[B030ORT5535C0]
Moist Heat or Steam Sterilization
[B030ORT5535C0]
Moist Heat or Steam Sterilization
[B030ORT5535C0]
Moist Heat or Steam Sterilization
[B030ORT5535C0]
Moist Heat or Steam Sterilization
[B030ORT5535C0]
Moist Heat or Steam Sterilization
[B030ORT5535C0]
Moist Heat or Steam Sterilization
[B030ORT5535C0]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-02-05 |
| Device Publish Date | 2019-01-18 |
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| B030EZO5020050 - Enza-O | 2024-07-30 8° Trial Caddy Body |
| B030EZO5020060 - Enza-O | 2024-07-30 15° Trial Caddy Body |
| B030EZO5030010 - Enza-O | 2024-07-30 8°, 26mm x 32mm Caddy Lid |
| B030EZO5030020 - Enza-O | 2024-07-30 8°, 30mm x 38mm Caddy Lid |
| B030EZO5030030 - Enza-O | 2024-07-30 15°, 26mm x 32mm Caddy Lid |