| Primary Device ID | 00817906022889 |
| NIH Device Record Key | 3e306e30-6c31-4bd4-abda-8512e8c3670c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fracture and Correction CoLag™ |
| Version Model Number | P65 ST128 |
| 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 | 00817906022889 [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 |
| 00817906022919 | SCREW, Ø2.5X10.0 mm |
| 00817906022902 | SCREW, Ø2.5X8.0 mm |
| 00817906022896 | SCREW, Ø2.0X30.0 mm |
| 00817906022889 | SCREW, Ø2.0X28.0 mm |
| 00817906022872 | SCREW, Ø2.0X26.0 mm |
| 00817906022865 | SCREW, Ø2.0X24.0 mm |
| 00817906022858 | SCREW, Ø2.0X22.0 mm |
| 00817906022841 | SCREW, Ø2.0X20.0 mm |
| 00817906022834 | SCREW, Ø2.0X18.0 mm |
| 00817906022827 | SCREW, Ø2.0X16.0 mm |
| 00817906022810 | SCREW, Ø2.0X15.0 mm |
| 00817906022803 | SCREW, Ø2.0X14.0 mm |
| 00817906022797 | SCREW, Ø2.0X13.0 mm |
| 00817906022780 | SCREW, Ø2.0X12.0 mm |
| 00817906022773 | SCREW, Ø2.0X11.0 mm |
| 00817906022766 | SCREW, Ø2.0X10.0 mm |
| 00817906022759 | SCREW, Ø2.0X9.0 mm |
| 00817906022742 | SCREW, Ø2.0X8.0 mm |