| Primary Device ID | 00196449034253 |
| NIH Device Record Key | a55a029e-3a4d-43a9-b50e-88cb8ce3dc59 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Anatomic Access LLIF |
| Version Model Number | NAV81180012 |
| Company DUNS | 010968002 |
| Company Name | Tyber Medical, 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 | 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 |
| regulatory@exalta.com | |
| Phone | +1(866)761-0933 |
| regulatory@exalta.com | |
| Phone | +1(866)761-0933 |
| regulatory@exalta.com | |
| Phone | +1(866)761-0933 |
| regulatory@exalta.com | |
| Phone | +1(866)761-0933 |
| regulatory@exalta.com | |
| Phone | +1(866)761-0933 |
| regulatory@exalta.com | |
| Phone | +1(866)761-0933 |
| regulatory@exalta.com | |
| Phone | +1(866)761-0933 |
| regulatory@exalta.com | |
| Phone | +1(866)761-0933 |
| regulatory@exalta.com | |
| Phone | +1(866)761-0933 |
| regulatory@exalta.com | |
| Phone | +1(866)761-0933 |
| regulatory@exalta.com | |
| Phone | +1(866)761-0933 |
| regulatory@exalta.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00196449034253 [Primary] |
| OLO | Orthopedic stereotaxic instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00196449034253]
Moist Heat or Steam Sterilization
[00196449034253]
Moist Heat or Steam Sterilization
[00196449034253]
Moist Heat or Steam Sterilization
[00196449034253]
Moist Heat or Steam Sterilization
[00196449034253]
Moist Heat or Steam Sterilization
[00196449034253]
Moist Heat or Steam Sterilization
[00196449034253]
Moist Heat or Steam Sterilization
[00196449034253]
Moist Heat or Steam Sterilization
[00196449034253]
Moist Heat or Steam Sterilization
[00196449034253]
Moist Heat or Steam Sterilization
[00196449034253]
Moist Heat or Steam Sterilization
[00196449034253]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-03 |
| Device Publish Date | 2025-11-25 |
| 00196449035113 | NAV, Anatomic Access LLIF, Cup Curette, 7mm, 45° Pull, Angled CC, RIGHT |
| 00196449035106 | NAV, Anatomic Access LLIF, Cup Curette, 7mm, Angled CC-15°, OUT |
| 00196449035090 | NAV, Anatomic Access LLIF, Cup Curette, 7mm. 45° Pull, Angled CC, LEFT |
| 00196449035083 | NAV, Anatomic Access LLIF, Cup Curette, 7mm, Angled CC-15°, IN |
| 00196449035076 | NAV, Anatomic Access LLIF, Cup Curette, 7mm, 45° Pull |
| 00196449035069 | NAV, Anatomic Access LLIF, Straight Cup Curette, 7mm |
| 00196449034901 | Anatomic Access LLIF, NAV 1, Middle Tray |
| 00196449034895 | Anatomic Access LLIF, NAV 1, Bottom Tray |
| 00196449034888 | Anatomic Access LLIF, NAV 1, Case |
| 00196449034871 | Anatomic Access LLIF, NON-NAV 3, Top Tray |
| 00196449034864 | Anatomic Access LLIF, NON-NAV 3, Middle Tray |
| 00196449034833 | Anatomic Access LLIF, NON-NAV 2, Top Tray |
| 00196449034789 | Anatomic Access LLIF, NON-NAV 1, Top Tray |
| 00196449034734 | NAV, Anatomic Access LLIF, Barrel Shaver 12mm |
| 00196449034727 | NAV, Anatomic Access LLIF, Barrel Shaver 10mm |
| 00196449034710 | NAV, Anatomic Access LLIF, Barrel Shaver 8mm |
| 00196449034703 | NAV, Anatomic Access LLIF, Barrel Shaver 6mm |
| 00196449034550 | NAV, Anatomic Access LLIF, Osteotome |
| 00196449034529 | Anatomic Access LLIF, Penfield Push #4 |
| 00196449034338 | NAV, Anatomic Access LLIF, Rasp, Angled CC-15°, Double Sided |
| 00196449034307 | NAV, Anatomic Access LLIF, Rasp, In-Line |
| 00196449034277 | Anatomic Access LLIF, Rasp, Angled CC-15° |
| 00196449034253 | NAV, Anatomic Access LLIF, Rotating Shaver 12mm |
| 00196449034246 | NAV, Anatomic Access LLIF, Rotating Shaver 10mm |
| 00196449034239 | NAV, Anatomic Access LLIF, Rotating Shaver 8mm |
| 00196449034222 | NAV, Anatomic Access LLIF, Rotating Shaver 6mm |
| 00196449034178 | NAV, Anatomic Access LLIF, Distractor, Angled CC-15°, 6mm x 18mm |
| 00196449034161 | NAV, Anatomic Access LLIF, Distractor, Angled CC-15°, 4mm x 15mm |
| 00196449034154 | NAV, Anatomic Access LLIF, Distractor - 6mm x 18mm |
| 00196449034147 | NAV, Anatomic Access LLIF, Distractor - 4mm x 15mm |
| 00196449034093 | NAV, Anatomic Access LLIF, Uterine Curette, Angled CC-15° |
| 00196449034086 | NAV, Anatomic Access LLIF, Cup Curette, 5mm, 45° Pull, Angled CC, RIGHT |
| 00196449034062 | NAV, Anatomic Access LLIF, Cup Curette, 5mm, Angled CC-15°, OUT |
| 00196449034048 | NAV, Anatomic Access LLIF, Cup Curette, 5mm. 45° Pull, Angled CC, LEFT |
| 00196449034024 | NAV, Anatomic Access LLIF, Cup Curette, 5mm, Angled CC-15°, IN |
| 00196449034000 | NAV, Anatomic Access LLIF, Uterine Curette |
| 00196449033997 | NAV, Anatomic Access LLIF, Cup Curette, 5mm, 45° Pull |
| 00196449033973 | NAV, Anatomic Access LLIF, Straight Cup Curette, 5mm |
| 00196449033935 | Anatomic Access LLIF, Cup Curette, 3mm, 45° Pull, Angled CC, OUT |
| 00196449033898 | Anatomic Access LLIF, Cup Curette, 3mm, 45° Pull, Angled CC-15°, IN |
| 00196449033874 | Anatomic Access LLIF, Cup Curette, 3mm, Angled CC-15°, IN |
| 00196449033812 | NAV Anatomic Access LLIF, Cobb, Angled CC-15°, IN, Sharp, 18mm |
| 00196449033799 | NAV Anatomic Access LLIF, Cobb, Angled CC-15° IN, 18mm |
| 00196449033775 | NAV Anatomic Access LLIF, Cobb Elevator, Sharp, 18mm |
| 00196449033768 | NAV Anatomic Access LLIF, Cobb Elevator - 18mm |
| 00196449033751 | NAV Anatomic Access LLIF, Cobb, Sharp, 22mm |
| 00196449033744 | NAV Anatomic Access LLIF, Cobb, Sharp, 18mm |
| 00196449033737 | NAV Anatomic Access LLIF, Cobb, Sharp, 10mm |
| 00196449033720 | NAV Anatomic Access LLIF, Cobb, 22mm |
| 00196449033713 | NAV Anatomic Access LLIF, Cobb, 18mm |