| Primary Device ID | M695HTR044546050 |
| NIH Device Record Key | b0dd30ab-b289-4367-9a66-5906aa0af7f2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Orion Headed Screw |
| Version Model Number | HTR-04-454605 |
| Catalog Number | HTR-04-454605 |
| Company DUNS | 010968002 |
| Company Name | Tyber Medical LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(866)761-0933 |
| ksimpkins@tybermed.com | |
| Phone | +1(866)761-0933 |
| ksimpkins@tybermed.com | |
| Phone | +1(866)761-0933 |
| ksimpkins@tybermed.com | |
| Phone | +1(866)761-0933 |
| ksimpkins@tybermed.com | |
| Phone | +1(866)761-0933 |
| ksimpkins@tybermed.com | |
| Phone | +1(866)761-0933 |
| ksimpkins@tybermed.com | |
| Phone | +1(866)761-0933 |
| ksimpkins@tybermed.com | |
| Phone | +1(866)761-0933 |
| ksimpkins@tybermed.com | |
| Phone | +1(866)761-0933 |
| ksimpkins@tybermed.com | |
| Phone | +1(866)761-0933 |
| ksimpkins@tybermed.com | |
| Phone | +1(866)761-0933 |
| ksimpkins@tybermed.com | |
| Phone | +1(866)761-0933 |
| ksimpkins@tybermed.com | |
| Phone | +1(866)761-0933 |
| ksimpkins@tybermed.com | |
| Phone | +1(866)761-0933 |
| ksimpkins@tybermed.com | |
| Phone | +1(866)761-0933 |
| ksimpkins@tybermed.com | |
| Phone | +1(866)761-0933 |
| ksimpkins@tybermed.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M695HTR044546050 [Primary] |
| HWC | Screw, fixation, bone |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2024-07-25 |
| Device Publish Date | 2019-08-23 |
| M695HTR046549800 | Headed Cannulated Screw Long-Thread Ø6.5mm-(L) 80mm |
| M695HTR046549550 | Headed Cannulated Screw Short-Thread Ø6.5mm-(L) 55mm |
| M695HTR046549380 | Headed Cannulated Screw Long-Thread Ø6.5mm-(L) 38mm |
| M695HTR046549000 | Headed Cannulated Screw Short-Thread Ø6.5mm-(L) 100mm |
| M695HTR046548950 | Headed Cannulated Screw Short-Thread Ø6.5mm-(L) 95mm |
| M695HTR046548750 | Headed Cannulated Screw Long-Thread Ø6.5mm-(L) 75mm |
| M695HTR046548500 | Headed Cannulated Screw Short-Thread Ø6.5mm-(L) 50mm |
| M695HTR046548360 | Headed Cannulated Screw Long-Thread Ø6.5mm-(L) 36mm |
| M695HTR046548200 | Headed Cannulated Screw Long-Thread Ø6.5mm-(L) 120mm |
| M695HTR046547900 | Headed Cannulated Screw Short-Thread Ø6.5mm-(L) 90mm |
| M695HTR046547700 | Headed Cannulated Screw Long-Thread Ø6.5mm-(L) 70mm |
| M695HTR046547450 | Headed Cannulated Screw Short-Thread Ø6.5mm-(L) 45mm |
| M695HTR046547340 | Headed Cannulated Screw Long-Thread Ø6.5mm-(L) 34mm |
| M695HTR046546100 | Headed Cannulated Screw Long-Thread Ø6.5mm-(L) 110mm |
| M695HTR046545600 | Headed Cannulated Screw Long-Thread Ø6.5mm-(L) 60mm |
| M695HTR046545300 | Headed Cannulated Screw Long-Thread Ø6.5mm-(L) 30mm |
| M695HTR046544360 | Headed Cannulated Screw Short-Thread Ø6.5mm-(L) 36mm |
| M695HTR046544200 | Headed Cannulated Screw Short-Thread Ø6.5mm-(L) 120mm |
| M695HTR046543950 | Headed Cannulated Screw Long-Thread Ø6.5mm-(L) 95mm |
| M695HTR046543500 | Headed Cannulated Screw Long-Thread Ø6.5mm-(L) 50mm |
| M695HTR046543340 | Headed Cannulated Screw Short-Thread Ø6.5mm-(L) 34mm |
| M695HTR046547150 | Headed Cannulated Screw Long-Thread Ø6.5mm-(L) 115mm |
| M695HTR046546850 | Headed Cannulated Screw Short-Thread Ø6.5mm-(L) 85mm |
| M695HTR046546650 | Headed Cannulated Screw Long-Thread Ø6.5mm-(L) 65mm |
| M695HTR046546400 | Headed Cannulated Screw Short-Thread Ø6.5mm-(L) 40mm |
| M695HTR046546320 | Headed Cannulated Screw Long-Thread Ø6.5mm-(L) 32mm |
| M695HTR046545800 | Headed Cannulated Screw Short-Thread Ø6.5mm-(L) 80mm |
| M695HTR046545380 | Headed Cannulated Screw Short-Thread Ø6.5mm-(L) 38mm |
| M695HTR046545050 | Headed Cannulated Screw Long-Thread Ø6.5mm-(L) 105mm |
| M695HTR046544750 | Headed Cannulated Screw Short-Thread Ø6.5mm-(L) 75mm |
| M695HTR046544550 | Headed Cannulated Screw Long-Thread Ø6.5mm-(L) 55mm |
| M695HTR046544000 | Headed Cannulated Screw Long-Thread Ø6.5mm-(L) 100mm |
| M695HTR046543700 | Headed Cannulated Screw Short-Thread Ø6.5mm-(L) 70mm |
| M695HTR046543150 | Headed Cannulated Screw Short-Thread Ø6.5mm-(L) 115mm |
| M695HTR046542900 | Headed Cannulated Screw Long-Thread Ø6.5mm-(L) 90mm |
| M695HTR046542650 | Headed Cannulated Screw Short-Thread Ø6.5mm-(L) 65mm |
| M695HTR046542450 | Headed Cannulated Screw Long-Thread Ø6.5mm-(L) 45mm |
| M695HTR046542320 | Headed Cannulated Screw Short-Thread Ø6.5mm-(L) 32mm |
| M695HTR046542100 | Headed Cannulated Screw Short-Thread Ø6.5mm-(L) 110mm |
| M695HTR046541850 | Headed Cannulated Screw Long-Thread Ø6.5mm-(L) 85mm |
| M695HTR046541600 | Headed Cannulated Screw Short-Thread Ø6.5mm-(L) 60mm |
| M695HTR046541400 | Headed Cannulated Screw Long-Thread Ø6.5mm-(L) 40mm |
| M695HTR046541300 | Headed Cannulated Screw Short-Thread Ø6.5mm-(L) 30mm |
| M695HTR046541050 | Headed Cannulated Screw Short-Thread Ø6.5mm-(L) 105mm |
| M695HTR044549750 | Headed Cannulated Screw Long-Thread Ø4.5mm-(L) 75mm |
| M695HTR044549600 | Headed Cannulated Screw Short-Thread Ø4.5mm-(L) 60mm |
| M695HTR044549450 | Headed Cannulated Screw Long-Thread Ø4.5mm-(L) 45mm |
| M695HTR044549340 | Headed Cannulated Screw Long-Thread Ø4.5mm-(L) 34mm |
| M695HTR044549300 | Headed Cannulated Screw Short-Thread Ø4.5mm-(L) 30mm |
| M695HTR044549050 | Headed Cannulated Screw Short-Thread Ø4.5mm-(L) 105mm |