| Primary Device ID | B648C2954000 |
| NIH Device Record Key | 7813435d-5121-4026-86c6-cdf1e096dd54 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Savant Lumbar Interbody Fusion System |
| Version Model Number | C295-400 |
| Company DUNS | 074575332 |
| Company Name | CURITEVA, INC. |
| 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 | 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 (877) 928-7483 |
| support@curiteva.com | |
| Phone | +1 (877) 928-7483 |
| support@curiteva.com | |
| Phone | +1 (877) 928-7483 |
| support@curiteva.com | |
| Phone | +1 (877) 928-7483 |
| support@curiteva.com | |
| Phone | +1 (877) 928-7483 |
| support@curiteva.com | |
| Phone | +1 (877) 928-7483 |
| support@curiteva.com | |
| Phone | +1 (877) 928-7483 |
| support@curiteva.com | |
| Phone | +1 (877) 928-7483 |
| support@curiteva.com | |
| Phone | +1 (877) 928-7483 |
| support@curiteva.com | |
| Phone | +1 (877) 928-7483 |
| support@curiteva.com | |
| Phone | +1 (877) 928-7483 |
| support@curiteva.com | |
| Phone | +1 (877) 928-7483 |
| support@curiteva.com | |
| Phone | +1 (877) 928-7483 |
| support@curiteva.com | |
| Phone | +1 (877) 928-7483 |
| support@curiteva.com | |
| Phone | +1 (877) 928-7483 |
| support@curiteva.com | |
| Phone | +1 (877) 928-7483 |
| support@curiteva.com | |
| Phone | +1 (877) 928-7483 |
| support@curiteva.com |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B648C2954000 [Primary] |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B648C2954000]
Moist Heat or Steam Sterilization
[B648C2954000]
Moist Heat or Steam Sterilization
[B648C2954000]
Moist Heat or Steam Sterilization
[B648C2954000]
Moist Heat or Steam Sterilization
[B648C2954000]
Moist Heat or Steam Sterilization
[B648C2954000]
Moist Heat or Steam Sterilization
[B648C2954000]
Moist Heat or Steam Sterilization
[B648C2954000]
Moist Heat or Steam Sterilization
[B648C2954000]
Moist Heat or Steam Sterilization
[B648C2954000]
Moist Heat or Steam Sterilization
[B648C2954000]
Moist Heat or Steam Sterilization
[B648C2954000]
Moist Heat or Steam Sterilization
[B648C2954000]
Moist Heat or Steam Sterilization
[B648C2954000]
Moist Heat or Steam Sterilization
[B648C2954000]
Moist Heat or Steam Sterilization
[B648C2954000]
Moist Heat or Steam Sterilization
[B648C2954000]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-01-12 |
| Device Publish Date | 2024-01-04 |
| B648C40432111600 | PEEK TLIF Spacer, 32 x 11 x 16mm, 0 deg |
| B648C40432111500 | PEEK TLIF Spacer, 32 x 11 x 15mm, 0 deg |
| B648C40432111400 | PEEK TLIF Spacer, 32 x 11 x 14mm, 0 deg |
| B648C40432111300 | PEEK TLIF Spacer, 32 x 11 x 13mm, 0 deg |
| B648C40432111200 | PEEK TLIF Spacer, 32 x 11 x 12mm, 0 deg |
| B648C40432111100 | PEEK TLIF Spacer, 32 x 11 x 11mm, 0 deg |
| B648C40432111000 | PEEK TLIF Spacer, 32 x 11 x 10mm, 0 deg |
| B648C40432110900 | PEEK TLIF Spacer, 32 x 11 x 9mm, 0 deg |
| B648C40432110800 | PEEK TLIF Spacer, 32 x 11 x 8mm, 0 deg |
| B648C40432110700 | PEEK TLIF Spacer, 32 x 11 x 7mm, 0 deg |
| B648C40432110600 | PEEK TLIF Spacer, 32 x 11 x 6mm, 0 deg |
| B648C40432091600 | PEEK TLIF Spacer, 32 x 9 x 16mm, 0 deg |
| B648C40432091500 | PEEK TLIF Spacer, 32 x 9 x 15mm, 0 deg |
| B648C40432091400 | PEEK TLIF Spacer, 32 x 9 x 14mm, 0 deg |
| B648C40432091300 | PEEK TLIF Spacer, 32 x 9 x 13mm, 0 deg |
| B648C40432091200 | PEEK TLIF Spacer, 32 x 9 x 12mm, 0 deg |
| B648C40432091100 | PEEK TLIF Spacer, 32 x 9 x 11mm, 0 deg |
| B648C40432091000 | PEEK TLIF Spacer, 32 x 9 x 10mm, 0 deg |
| B648C40432090900 | PEEK TLIF Spacer, 32 x 9 x 9mm, 0 deg |
| B648C40432090800 | PEEK TLIF Spacer, 32 x 9 x 8mm, 0 deg |
| B648C40432090700 | PEEK TLIF Spacer, 32 x 9 x 7mm, 0 deg |
| B648C40432090600 | PEEK TLIF Spacer, 32 x 9 x 6mm, 0 deg |
| B648C40428111600 | PEEK TLIF Spacer, 28 x 11 x 16mm, 0 deg |
| B648C40428111500 | PEEK TLIF Spacer, 28 x 11 x 15mm, 0 deg |
| B648C40428111400 | PEEK TLIF Spacer, 28 x 11 x 14mm, 0 deg |
| B648C40428111300 | PEEK TLIF Spacer, 28 x 11 x 13mm, 0 deg |
| B648C40428111200 | PEEK TLIF Spacer, 28 x 11 x 12mm, 0 deg |
| B648C40428111100 | PEEK TLIF Spacer, 28 x 11 x 11mm, 0 deg |
| B648C40428111000 | PEEK TLIF Spacer, 28 x 11 x 10mm, 0 deg |
| B648C40428110900 | PEEK TLIF Spacer, 28 x 11 x 9mm, 0 deg |
| B648C40428110800 | PEEK TLIF Spacer, 28 x 11 x 8mm, 0 deg |
| B648C40428110700 | PEEK TLIF Spacer, 28 x 11 x 7mm, 0 deg |
| B648C40428110600 | PEEK TLIF Spacer, 28 x 11 x 6mm, 0 deg |
| B648C40428091600 | PEEK TLIF Spacer, 28 x 9 x 16mm, 0 deg |
| B648C40428091500 | PEEK TLIF Spacer, 28 x 9 x 15mm, 0 deg |
| B648C40428091400 | PEEK TLIF Spacer, 28 x 9 x 14mm, 0 deg |
| B648C40428091300 | PEEK TLIF Spacer, 28 x 9 x 13mm, 0 deg |
| B648C40428091200 | PEEK TLIF Spacer, 28 x 9 x 12mm, 0 deg |
| B648C40428091100 | PEEK TLIF Spacer, 28 x 9 x 11mm, 0 deg |
| B648C40428091000 | PEEK TLIF Spacer, 28 x 9 x 10mm, 0 deg |
| B648C40428090900 | PEEK TLIF Spacer, 28 x 9 x 9mm, 0 deg |
| B648C40428090800 | PEEK TLIF Spacer, 28 x 9 x 8mm, 0 deg |
| B648C40428090700 | PEEK TLIF Spacer, 28 x 9 x 7mm, 0 deg |
| B648C40428090600 | PEEK TLIF Spacer, 28 x 9 x 6mm, 0 deg |
| B648C30430101680 | PEEK PLIF Spacer, 30 x 10 x 16mm, 8 deg |
| B648C30430101600 | PEEK PLIF Spacer, 30 x 10 x 16mm, 0 deg |
| B648C30430101580 | PEEK PLIF Spacer, 30 x 10 x 15mm, 8 deg |
| B648C30430101500 | PEEK PLIF Spacer, 30 x 10 x 15mm, 0 deg |
| B648C30430101480 | PEEK PLIF Spacer, 30 x 10 x 14mm, 8 deg |
| B648C30430101400 | PEEK PLIF Spacer, 30 x 10 x 14mm, 0 deg |