| Primary Device ID | D824PFRC35152 |
| NIH Device Record Key | 86420332-115d-4ddb-ae5d-50b8ca68451b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fixation Implant Pack |
| Version Model Number | PFRC3515 |
| Company DUNS | 080321629 |
| Company Name | SURGIKOR, 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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 | D824PFRC35150 [Primary] |
| HIBCC | D824PFRC35151 [Package] Contains: D824PFRC35150 Package: [10 Units] In Commercial Distribution |
| HIBCC | D824PFRC35152 [Package] Contains: D824PFRC35150 Package: [4 Units] In Commercial Distribution |
| DZE | Implant, Endosseous, Root-Form |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-01-31 |
| D824PFWC50182 | Ø5.0mm x L18.0mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PFWC50152 | Ø5.0mm x L15.0mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PFWC50132 | Ø5.0mm x L13.0mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PFWC50112 | Ø5.0mm x L11.5mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PFWC50102 | Ø5.0mm x L10.0mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PFWC50082 | Ø5.0mm x L8.5mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PFWC43182 | Ø4.3mm x L18.0mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PFWC43152 | Ø4.3mm x L15.0mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PFWC43132 | Ø4.3mm x L13.0mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PFWC43112 | Ø4.3mm x L11.5mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PFWC43102 | Ø4.3mm x L10.0mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PFWC43082 | Ø4.3mm x L8.5mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PFRC35182 | Ø3.5mm x L18.0mm, Conical Connection, Regular Platform with Cover Screw & Mount |
| D824PFRC35152 | Ø3.5mm x L15.0mm, Conical Connection, Regular Platform with Cover Screw & Mount |
| D824PFRC35132 | Ø3.5mm x L13.0mm, Conical Connection, Regular Platform with Cover Screw & Mount |
| D824PFRC35112 | Ø3.5mm x L11.5mm, Conical Connection, Regular Platform with Cover Screw & Mount |
| D824PFRC35102 | Ø3.5mm x L10.0mm, Conical Connection, Regular Platform with Cover Screw & Mount |
| D824PFRC35082 | Ø3.5mm x L8.5mm, Conical Connection, Regular Platform with Cover Screw & Mount |
| D824PFNC30152 | Ø3.0mm x L15.0mm, Conical Connection, Narrow Platform with Cover Screw & Mount |
| D824PFNC30132 | Ø3.0mm x L13.0mm, Conical Connection, Narrow Platform with Cover Screw & Mount |
| D824PFNC30112 | Ø3.0mm x L11.5mm, Conical Connection, Narrow Platform with Cover Screw & Mount |
| D824PFNC30102 | Ø3.0mm x L10mm, Conical Connection, Narrow Platform with Cover Screw & Mount |