| Primary Device ID | B030SCZ500002010 |
| NIH Device Record Key | 6012d371-16e0-467e-9b42-90870f1f439b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SPIRA-C Integrated |
| Version Model Number | SCZ-500-002-01 |
| Catalog Number | NA |
| Company DUNS | 054205979 |
| Company Name | CAMBER SPINE TECHNOLOGIES, 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 | 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 |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B030SCZ500002010 [Primary] |
| FSM | Tray, Surgical, Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B030SCZ500002010]
Moist Heat or Steam Sterilization
[B030SCZ500002010]
Moist Heat or Steam Sterilization
[B030SCZ500002010]
Moist Heat or Steam Sterilization
[B030SCZ500002010]
Moist Heat or Steam Sterilization
[B030SCZ500002010]
Moist Heat or Steam Sterilization
[B030SCZ500002010]
Moist Heat or Steam Sterilization
[B030SCZ500002010]
Moist Heat or Steam Sterilization
[B030SCZ500002010]
Moist Heat or Steam Sterilization
[B030SCZ500002010]
Moist Heat or Steam Sterilization
[B030SCZ500002010]
Moist Heat or Steam Sterilization
[B030SCZ500002010]
Moist Heat or Steam Sterilization
[B030SCZ500002010]
Moist Heat or Steam Sterilization
[B030SCZ500002010]
Moist Heat or Steam Sterilization
[B030SCZ500002010]
Moist Heat or Steam Sterilization
[B030SCZ500002010]
Moist Heat or Steam Sterilization
[B030SCZ500002010]
Moist Heat or Steam Sterilization
[B030SCZ500002010]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-23 |
| Device Publish Date | 2024-05-15 |
| B030SCZ1042000 | Implant Inserter |
| B030SCZ5040020 | Screw, Caddy Base |
| B030SCZ5040010 | Inserter Jaw, Caddy Base |
| B030SCZ5030010 | Inserter Jaw, Caddy Lid |
| B030SCZ1200010 | Drill Guide, Variable Angle |
| B030SCZ1100010 | Tap, Ø3.5mm |
| B030SCZ1080180 | Drill, 2.5mm, 18mm |
| B030SCZ1080160 | Drill, 2.5mm, 16mm |
| B030SCZ1080140 | Drill, 2.5mm, 14mm |
| B030SCZ1080120 | Drill, 2.5mm, 12mm |
| B030SCZ1060020 | Awl, Curved |
| B030SCZ1060010 | Awl, Cervical |
| B030SCZ1050030 | Screwdriver, Ball-Joint T10 |
| B030SCZ1170100 | Self-Retaining T10, Screwdriver |
| B030SCZ1040120 | Tip, Inserter Guided, 12mm |
| B030SCZ1040110 | Tip, Inserter Guided, 11mm |
| B030SCZ1040100 | Tip, Inserter Guided, 10mm |
| B030SCZ1040090 | Tip, Inserter Guided, 9mm |
| B030SCZ1040080 | Tip, Inserter Guided, 8mm |
| B030SCZ1040070 | Tip, Inserter Guided, 7mm |
| B030SCZ1040060 | Tip, Inserter Guided, 6mm |
| B030SCZ1040020 | Tip, Inserter with Stops, Streamline |
| B030SCZ1040010 | Tip, Inserter, Streamline |
| B030SCZ1030010 | Assy, Inline Inserter |
| B030SCZ5040040 | Anchor Caddy Lid |
| B030SCZ5040030 | Anchor Caddy |
| B030SCZ5030030 | Anchor Caddy Lid |
| B030SCZ501010 | Case Lid |
| B030SCZ5000030 | Anchor Instrument Tray |
| B030SCZ500002020 | Instrument Tray |
| B030SCZ500002010 | Trial Tray |
| B030SCZ5000010 | Modular Case |
| B030SCZ1350010 | Anchor Removal Tool |
| B030SCZ1210020 | Anchor Insertion Ram |
| B030SCZ1043000 | Mallet |
| B030SCZ1033120 | Captivated Inserter Tip, 12mm |
| B030SCZ1033100 | Captivated Inserter Tip, 10mm-11mm |
| B030SCZ1033080 | Captivated Inserter Tip, 8mm-9mm |
| B030SCZ1033060 | Captivated Inserter Tip, 6mm-7mm |
| B030SCZ1033010 | Anchor Introducer |
| B030SCZ10180 | Anchor, SPIRA-C Integrated, 18mm |
| B030SCZ10160 | Anchor, SPIRA-C Integrated, 16mm |
| B030SCZ10140 | Anchor, SPIRA-C Integrated, 14mm |
| B030SCZ10120 | Anchor, SPIRA-C Integrated, 12mm |
| B030SCZ1010010 | Inline Inserter |
| B030SCA151807080 | 15mm x 18mm, 7° Lordotic, 8mm |
| B030SCA151807070 | 15mm x 18mm, 7° Lordotic 7mm |
| B030SCA151807060 | 15mm x 18mm, 7° Lordotic, 6mm |
| B030SCA141607120 | 14mm x 16mm, 7° Lordotic, 12mm |
| B030SCA141607110 | 14mm x 16mm, 7° Lordotic, 11mm |