| Primary Device ID | B57112521112080D0 |
| NIH Device Record Key | f4639fd0-33f2-49df-a6f4-f14f85cfeec1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Integrity-SI Fusion System |
| Version Model Number | 1252-1112-080 |
| Catalog Number | 1252-1112-080 |
| Company DUNS | 010321068 |
| Company Name | COORSTEK MEDICAL 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B57112521112080D0 [Primary] |
| OUR | Sacroiliac Joint Fixation |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B57112521112080D0]
Moist Heat or Steam Sterilization
[B57112521112080D0]
Moist Heat or Steam Sterilization
[B57112521112080D0]
Moist Heat or Steam Sterilization
[B57112521112080D0]
Moist Heat or Steam Sterilization
[B57112521112080D0]
Moist Heat or Steam Sterilization
[B57112521112080D0]
Moist Heat or Steam Sterilization
[B57112521112080D0]
Moist Heat or Steam Sterilization
[B57112521112080D0]
Moist Heat or Steam Sterilization
[B57112521112080D0]
Moist Heat or Steam Sterilization
[B57112521112080D0]
Moist Heat or Steam Sterilization
[B57112521112080D0]
Moist Heat or Steam Sterilization
[B57112521112080D0]
Moist Heat or Steam Sterilization
[B57112521112080D0]
Moist Heat or Steam Sterilization
[B57112521112080D0]
Moist Heat or Steam Sterilization
[B57112521112080D0]
Moist Heat or Steam Sterilization
[B57112521112080D0]
Moist Heat or Steam Sterilization
[B57112521112080D0]
Moist Heat or Steam Sterilization
[B57112521112080D0]
Moist Heat or Steam Sterilization
[B57112521112080D0]
Moist Heat or Steam Sterilization
[B57112521112080D0]
Moist Heat or Steam Sterilization
[B57112521112080D0]
Moist Heat or Steam Sterilization
[B57112521112080D0]
Moist Heat or Steam Sterilization
[B57112521112080D0]
Moist Heat or Steam Sterilization
[B57112521112080D0]
Moist Heat or Steam Sterilization
[B57112521112080D0]
Moist Heat or Steam Sterilization
[B57112521112080D0]
Moist Heat or Steam Sterilization
[B57112521112080D0]
Moist Heat or Steam Sterilization
[B57112521112080D0]
Moist Heat or Steam Sterilization
[B57112521112080D0]
Moist Heat or Steam Sterilization
[B57112521112080D0]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-08-09 |
| Device Publish Date | 2018-07-09 |
| B57112525510E0 | Center Shaft |
| B57112525500F0 | BLADEX Handpiece |
| B57112525265C0 | T-Handle Ratcheting Handle |
| B57112525260C0 | In-Line Ratcheting Handle |
| B57112525251C0 | Nav Adapter |
| B57112525250C0 | Power Adapter |
| B57112525212E0 | 24mm Cannula |
| B57112525200000E0 | Suction Tube |
| B57112525190000E0 | Implant Length Gauge |
| B57112525186000E0 | Graft Inserter Ram |
| B57112525180000D0 | Graft Inserter Funnel |
| B57112525145000E0 | Removal Tool |
| B57112525103000E0 | 3.2 mm Stabilizing Guide Pin |
| B57112525020000D0 | 2.0 mm Pin Guide |
| B57112524401D0 | 24mm Nav Sleeve |
| B57112524400E0 | 12mm Sleeve |
| B57112524220F0 | 24mm Dilator |
| B57112524140D0 | Hex Driver - Large |
| B57112524135D0 | Hex Driver - Small |
| B57112524131D0 | Impactor - Long |
| B57112524130D0 | Cannula Impactor |
| B57112524120E0 | 18mm Dilator |
| B57112524110E0 | 12mm Dilator |
| B57112524109E0 | 4.0mm Drill |
| B57112524108D0 | 6.0mm Drill |
| B57112524107D0 | 7.5mm Drill |
| B57112524106D0 | 12mm drill |
| B57112524102003D0 | Extra Long 3.2mm Guide Pin |
| B57112524102002D0 | Short 3.2mm Guide Pin |
| B57112524102001D0 | Long 3.2mm Guide Pin |
| B57112524100D0 | 2.0mm Guide Pin |
| B57112521112111D0 | 12 x 110 mm SI Implant Fully Threaded with HA Coating |
| B57112521112110D0 | 12 x 110 mm Anodized SI Implant Fully Threaded |
| B57112521112106D0 | 12 x 105 mm SI Implant Fully Threaded with HA Coating |
| B57112521112105D0 | 12 x 105 mm Anodized SI Implant Fully Threaded |
| B57112521112101D0 | 12 x 100 mm SI Implant Fully Threaded with HA Coating |
| B57112521112100D0 | 12 x 100 mm Anodized SI Implant Fully Threaded |
| B57112521112096D0 | 12 x 95 mm SI Implant Fully Threaded with HA Coating |
| B57112521112095D0 | 12 x 95 mm Anodized SI Implant Fully Threaded |
| B57112521112091D0 | 12 x 90 mm SI Implant Fully Threaded with HA Coating |
| B57112521112090D0 | 12 x 90 mm Anodized SI Implant Fully Threaded |
| B57112521112086D0 | 12 x 85 mm SI Implant Fully Threaded with HA Coating |
| B57112521112085D0 | 12 x 85 mm Anodized SI Implant Fully Threaded |
| B57112521112081D0 | 12 x 80 mm SI Implant Fully Threaded with HA Coating |
| B57112521112080D0 | 12 x 80 mm Anodized SI Implant Fully Threaded |
| B57112521112076D0 | 12 x 75 mm SI Implant Fully Threaded with HA Coating |
| B57112521112075D0 | 12 x 75 mm Anodized SI Implant Fully Threaded |
| B57112521112071D0 | 12 x 70 mm SI Implant Fully Threaded with HA Coating |
| B57112521112070D0 | 12 x 70 mm Anodized SI Implant Fully Threaded |
| B57112521112066D0 | 12 x 65 mm SI Implant Fully Threaded with HA Coating |