| Primary Device ID | 00819917026832 |
| NIH Device Record Key | ccb76fb0-53b4-4d60-a8b9-7d65642f3c27 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cannulated Screw System + |
| Version Model Number | 03.333.213S |
| Catalog Number | 03.333.213S |
| Company DUNS | 010968002 |
| Company Name | Tyber Medical, 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 | 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 |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00819917026832 [Primary] |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2025-08-15 |
| Device Publish Date | 2020-05-21 |
| 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 |