| Primary Device ID | 00817906029710 |
| NIH Device Record Key | 692d44c5-0136-41b7-a391-21b43c7f405d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | In2Bones USA |
| Version Model Number | P06 N0071 |
| Company DUNS | 079700711 |
| Company Name | IN2BONES USA, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817906029710 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00817906029710]
Moist Heat or Steam Sterilization
[00817906029710]
Moist Heat or Steam Sterilization
[00817906029710]
Moist Heat or Steam Sterilization
[00817906029710]
Moist Heat or Steam Sterilization
[00817906029710]
Moist Heat or Steam Sterilization
[00817906029710]
Moist Heat or Steam Sterilization
[00817906029710]
Moist Heat or Steam Sterilization
[00817906029710]
Moist Heat or Steam Sterilization
[00817906029710]
Moist Heat or Steam Sterilization
[00817906029710]
Moist Heat or Steam Sterilization
[00817906029710]
Moist Heat or Steam Sterilization
[00817906029710]
Moist Heat or Steam Sterilization
[00817906029710]
Moist Heat or Steam Sterilization
[00817906029710]
Moist Heat or Steam Sterilization
[00817906029710]
Moist Heat or Steam Sterilization
[00817906029710]
Moist Heat or Steam Sterilization
[00817906029710]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-06-24 |
| Device Publish Date | 2019-06-14 |
| 00817906029994 | Lag Screw Countersink, 2.0/2.5 |
| 00817906029987 | Lag Screw Drill, Cannulated 1.6 |
| 00817906029970 | Lag Screw Driver, T7 Cannulated |
| 00817906029963 | LAG SCREW COUNTERSINK, HUDSON, Ø5.0 |
| 00817906029956 | LAG SCREW DRILL, CANNULATED, HUDSON, Ø4.8 |
| 00817906029949 | LAG SCREW DRILL, CANNULATED, HUDSON, Ø3.3 |
| 00817906029932 | K-WIRE, S. TROCAR, SMOOTH, .031X4" |
| 00817906029925 | LAG SCREW COUNTERSINK, Ø6.7 |
| 00817906029918 | LAG SCREW COUNTERSINK, Ø4.0/Ø5.0 |
| 00817906029901 | LAG SCREW COUNTERSINK, Ø3.0 |
| 00817906029895 | LAG SCREW DRILL, CANNULATED, Ø4.8 |
| 00817906029888 | LAG SCREW DRILL, CANNULATED, Ø3.3 |
| 00817906029871 | LAG SCREW DRILL, CANNULATED, Ø2.7 |
| 00817906029864 | LAG SCREW DRILL, CANNULATED, Ø2.1 |
| 00817906029857 | LAG SCREW DRIVER, T15, CANNULATED |
| 00817906029840 | LAG SCREW DRIVER, T8, CANNULATED |
| 00817906029833 | K-WIRE, S. TROCAR, SMOOTH, .087X7" |
| 00817906029826 | K-WIRE, S. TROCAR, SMOOTH, .062X6" |
| 00817906029819 | K-WIRE, S. TROCAR, SMOOTH, .062X7" |
| 00817906029802 | K-WIRE, S. TROCAR, SMOOTH, .062X5" |
| 00817906029796 | K-WIRE, S. TROCAR, SMOOTH, .045X6" |
| 00817906029789 | K-WIRE, S. TROCAR, SMOOTH, .045X5" |
| 00817906029772 | 1.6MMX9" SINGLE TROCAR, SMOOTH, K-WIRE |
| 00817906029765 | 2.2MMX9" SINGLE TROCAR, SMOOTH, STEINMANN PIN |
| 00817906029758 | 5MS, JONES SCREW TAP, Ø6.0 |
| 00817906029741 | 5MS, JONES SCREW TAP, Ø5.5 |
| 00817906029734 | 5MS, JONES SCREW TAP, Ø4.5 |
| 00817906029727 | 5MS, CANNULATED JONES DRILL, Ø4.5 |
| 00817906029710 | 5MS, CANNULATED JONES DRILL, Ø3.5 |
| 00817906029703 | 5MS, SMALL SCREW DRILL, Ø1.9 |
| 00817906029697 | 5MS, SMALL SCREW DRILL, Ø1.6 |
| 00817906029680 | 5MS, T25 DRIVER, CANNULATED, AO |
| 00817906029673 | 5MS, T15 DRIVER, CANNULATED, AO |
| 00817906029666 | 5MS, T7 DRIVER, SOLID, AO |
| 00817906029659 | 2.5 mm Drill Bit |
| 00817906029642 | 2.0 mm Drill Bit |
| 00817906029635 | Olive Wire .045 x 2.5" |
| 00817906029628 | T-8 Driver Bit |
| 00817906029611 | T-8 Driver Bit |
| 00817906029604 | Reamer, 2.9 mm Diameter, Non-Sterile |
| 00817906029598 | Reamer, 2.4 mm Diameter, Non-Sterile |
| 00817906029581 | .045 x 4.0 in. K-wire, double diamond, Non-Sterile |
| 00810021861302 | AFX, Lag Guide, Ø1.9 |
| 00810021861296 | AFX, Lag Guide, Ø2.5 |
| 00810021861289 | NL Drill Guide, 2.5 & 3.5, Assy |
| 00810021861272 | NL Drill Guide, 1.9 & 2.7, Assy |
| 00810021861265 | Lag Screw Sizer, X-Small |
| 00810021861258 | LAG SCREW SIZER, 9" WIRE |
| 00810021861241 | LAG SCREW SIZER, 6" WIRE |
| 00810021861234 | LAG SCREW WIRE GUIDE, Ø6.7 |