| Primary Device ID | 00817906024456 |
| NIH Device Record Key | 2ebaa505-eb7e-4505-9edd-ea3be38e5d58 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fracture and Correction CoLag™ 2 |
| Version Model Number | P67 ST645 |
| Company DUNS | 079700711 |
| Company Name | IN2BONES USA, 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 | 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 |
|---|---|
| GS1 | 00817906024456 [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 | 2018-09-06 |
| Device Publish Date | 2018-08-06 |
| 00817906024487 | SCREW, Ø6.7X52.5 mm |
| 00817906024470 | SCREW, Ø6.7X50.0 mm |
| 00817906024463 | SCREW, Ø6.7X47.5 mm |
| 00817906024456 | SCREW, Ø6.7X45.0 mm |
| 00817906024449 | SCREW, Ø6.7X42.5 mm |
| 00817906024432 | SCREW, Ø6.7X40.0 mm |
| 00817906024425 | 2 SCREW, Ø6.7X38.0 mm |
| 00817906024418 | SCREW, Ø6.7X36.0 mm |
| 00817906024401 | SCREW, Ø6.7X34.0 mm |
| 00817906024395 | SCREW, Ø6.7X32.0 mm |
| 00817906024388 | SCREW, Ø6.7X30.0 mm |
| 00817906024371 | SCREW, Ø5.0X70.0 mm |
| 00817906024364 | SCREW, Ø5.0X67.5 mm |
| 00817906024357 | SCREW, Ø5.0X65.0 mm |