| Primary Device ID | B487EXINF9220360 |
| NIH Device Record Key | 9913f51e-287f-483e-80a4-8f7225256c38 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | InFrame Implant |
| Version Model Number | EXINF922036 |
| Catalog Number | EXINF922036 |
| Company DUNS | 116722111 |
| Company Name | Exsomed Corporation |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Outer Diameter | 2 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 36 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B487EXINF9220360 [Primary] |
| HWC | Screw, Fixation, Bone |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-10-05 |
| Device Publish Date | 2021-09-27 |
| B487EXINF9220100 | InFrame is a stainless steel bone screw. |
| B487EXINF9220500 | InFrame is a stainless steel bone screw. |
| B487EXINF9220480 | InFrame is a stainless steel bone screw. |
| B487EXINF9220460 | InFrame is a stainless steel bone screw. |
| B487EXINF9220440 | InFrame is a stainless steel bone screw. |
| B487EXINF9220420 | InFrame is a stainless steel bone screw. |
| B487EXINF9220400 | InFrame is a stainless steel bone screw. |
| B487EXINF9220380 | InFrame is a stainless steel bone screw. |
| B487EXINF9220360 | InFrame is a stainless steel bone screw. |
| B487EXINF9220340 | InFrame is a stainless steel bone screw. |
| B487EXINF9220320 | InFrame is a stainless steel bone screw. |
| B487EXINF9220300 | InFrame is a stainless steel bone screw. |
| B487EXINF9220280 | InFrame is a stainless steel bone screw. |
| B487EXINF9220260 | InFrame is a stainless steel bone screw. |
| B487EXINF9220240 | InFrame is a stainless steel bone screw. |
| B487EXINF9220220 | InFrame is a stainless steel bone screw. |
| B487EXINF9220200 | InFrame is a stainless steel bone screw. |
| B487EXINF9220180 | InFrame is a stainless steel bone screw. |
| B487EXINF9220160 | InFrame is a stainless steel bone screw. |
| B487EXINF9220140 | InFrame is a stainless steel bone screw. |
| B487EXINF9220120 | InFrame is a stainless steel bone screw. |