| Primary Device ID | B946024000070 |
| NIH Device Record Key | 34e9dfdd-9b01-4d4d-a23d-99460353f6a4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NuFix II |
| Version Model Number | IR |
| Catalog Number | 02.400.007 |
| Company DUNS | 080867996 |
| Company Name | NUTECH SPINE, INC. |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B946024000070 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B946024000070]
Moist Heat or Steam Sterilization
[B946024000070]
Moist Heat or Steam Sterilization
[B946024000070]
Moist Heat or Steam Sterilization
[B946024000070]
Moist Heat or Steam Sterilization
[B946024000070]
Moist Heat or Steam Sterilization
[B946024000070]
Moist Heat or Steam Sterilization
[B946024000070]
Moist Heat or Steam Sterilization
[B946024000070]
Moist Heat or Steam Sterilization
[B946024000070]
Moist Heat or Steam Sterilization
[B946024000070]
Moist Heat or Steam Sterilization
[B946024000070]
Moist Heat or Steam Sterilization
[B946024000070]
Moist Heat or Steam Sterilization
[B946024000070]
Moist Heat or Steam Sterilization
[B946024000070]
Moist Heat or Steam Sterilization
[B946024000070]
Moist Heat or Steam Sterilization
[B946024000070]
Moist Heat or Steam Sterilization
[B946024000070]
Moist Heat or Steam Sterilization
[B946024000070]
Moist Heat or Steam Sterilization
[B946024000070]
Moist Heat or Steam Sterilization
[B946024000070]
Moist Heat or Steam Sterilization
[B946024000070]
Moist Heat or Steam Sterilization
[B946024000070]
Moist Heat or Steam Sterilization
[B946024000070]
Moist Heat or Steam Sterilization
[B946024000070]
Moist Heat or Steam Sterilization
[B946024000070]
Moist Heat or Steam Sterilization
[B946024000070]
Moist Heat or Steam Sterilization
[B946024000070]
Moist Heat or Steam Sterilization
[B946024000070]
Moist Heat or Steam Sterilization
[B946024000070]
Moist Heat or Steam Sterilization
[B946024000070]
Moist Heat or Steam Sterilization
[B946024000070]
Moist Heat or Steam Sterilization
[B946024000070]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-02 |
| Device Publish Date | 2020-09-24 |
| B946NFII600CIR0 | NuFix II Cannulated Blade |
| B946NFII600C0 | NuFix II Cannulated Blade Rev. 01 |
| B946NFII6000 | NuFix II Non-Cannulated Blade |
| B946NFII500IR0 | NuFix II Inserter |
| B946NFII5000 | NuFix II Inserter Rev. 01 |
| B946NFII4020 | NuFix II Drill, 5.0mm Rev. 01 |
| B946NFII300IR0 | NuFix II Drill Guide |
| B946NFII3000 | NuFix II Drill Guide Rev. 01 |
| B946NFII200IR0 | Drill Bushing Center Hole |
| B946NFII200DIR0 | Drill Bushing Two Holes |
| B946NFII200D0 | Drill Bushing Two Holes Rev. 01 |
| B946NFII2000 | Drill Bushing Center Hole Rev. 01 |
| B946024000070 | NuFix II Drill, 4.5mm - Stepped, Undersized |
| B946024000060 | NuFix II Drill, 4.5mm - Stepped |
| B946024000050 | NuFix II Drill, 4.5mm-Tapered, Undersized |
| B946024000040 | NuFix II Drill, 4.5mm - Tapered |
| B946024000030 | NuFix II Broach |
| B946024000010 | NuFix II Drill, 4.5mm |
| B946021000010 | NuFix II Go/No-Go Gage |