| Primary Device ID | M6950100000010 |
| NIH Device Record Key | 19c85987-4d31-493a-bd3c-4d3c587122f1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Snap-Off Screw System Instruments |
| Version Model Number | 010-000001 |
| Catalog Number | 010-000001 |
| 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M6950100000010 [Primary] |
| LRZ | Screwdriver, surgical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2025-08-15 |
| Device Publish Date | 2019-08-23 |
| 00196449033638 - Anatomic Access LLIF | 2025-12-18 Anatomic Access LLIF, Cobb, Sharp, 22mm |
| 00196449033669 - Anatomic Access LLIF | 2025-12-18 Anatomic Access LLIF, Cobb, Angled CC-15° OUT, 18mm |
| 00196449033683 - Anatomic Access LLIF | 2025-12-18 Anatomic Access LLIF, Cobb, Angled CC-15° OUT, Sharp, 18mm |
| 00196449035007 - Anatomic Access LLIF | 2025-12-18 Anatomic Access LLIF, Straight Cup Curette, 7mm |
| 00196449035014 - Anatomic Access LLIF | 2025-12-18 Anatomic Access LLIF, Cup Curette, 7mm, 45° Pull |
| 00196449035021 - Anatomic Access LLIF | 2025-12-18 Anatomic Access LLIF, Cup Curette, 7mm, Angled CC-15° IN |
| 00196449035038 - Anatomic Access LLIF | 2025-12-18 Anatomic Access LLIF, Cup Curette, 7mm, 45° Pull, Angled CC-15°, LEFT |
| 00196449035045 - Anatomic Access LLIF | 2025-12-18 Anatomic Access LLIF, Cup Curette, 7mm, Angled CC-15° OUT |