| Primary Device ID | 00848665036053 |
| NIH Device Record Key | f2fb2cdf-5703-4375-ab0f-d1fec7e64fbc |
| Commercial Distribution Discontinuation | 2025-10-01 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | SILICONE PALM HANDLE, PULL BACK AO CONNECTION |
| Version Model Number | 5035-100 |
| Company DUNS | 117858154 |
| Company Name | ADVANCED ORTHOPAEDIC SOLUTIONS, INC. |
| 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 | 3105339966 |
| regaffairs@aosortho.com | |
| Phone | 3105339966 |
| regaffairs@aosortho.com | |
| Phone | 3105339966 |
| regaffairs@aosortho.com | |
| Phone | 3105339966 |
| regaffairs@aosortho.com | |
| Phone | 3105339966 |
| regaffairs@aosortho.com | |
| Phone | 3105339966 |
| regaffairs@aosortho.com | |
| Phone | 3105339966 |
| regaffairs@aosortho.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00848665036053 [Primary] |
| HRS | Plate, Fixation, Bone |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00848665036053]
Moist Heat or Steam Sterilization
[00848665036053]
Moist Heat or Steam Sterilization
[00848665036053]
Moist Heat or Steam Sterilization
[00848665036053]
Moist Heat or Steam Sterilization
[00848665036053]
Moist Heat or Steam Sterilization
[00848665036053]
Moist Heat or Steam Sterilization
[00848665036053]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2026-01-26 |
| Device Publish Date | 2020-06-16 |
| 00848665035667 - TARGETER ALIGNMENT LOCK | 2026-01-26 |
| 00848665035674 - TARGETER ALIGNMENT POST | 2026-01-26 |
| 00848665036039 - FIXED SMALL AXIAL HANDLE. AO QUICK CONNECT, CANNULATED | 2026-01-26 |
| 00848665036046 - RATCHETING SMALL AXIAL HANDLE, AO QUICK CONNECT, CANNULATED | 2026-01-26 |
| 00848665036053 - SILICONE PALM HANDLE, PULL BACK AO CONNECTION | 2026-01-26 |
| 00848665036053 - SILICONE PALM HANDLE, PULL BACK AO CONNECTION | 2026-01-26 |
| 00848665036305 - ES™ TROCHANTERIC NAIL, LEFT, 12.5mm x 30cm x 125 GOLD | 2026-01-26 |
| 00848665036343 - ES™ TROCHANTERIC NAIL, LEFT, 12.5mm x 42cm x 125 GOLD | 2026-01-26 |
| 00848665036374 - ES™ TROCHANTERIC NAIL, RIGHT, 12.5mm x 30cm x 125 PURPLE | 2026-01-26 |