NuFix NF-1004
GUDID B946NF10040
Facet Sound
NUTECH SPINE, INC.
External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system| Primary Device ID | B946NF10040 |
| NIH Device Record Key | fda9713e-2674-462d-99cd-69aa0c6934a5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NuFix |
| Version Model Number | IR |
| Catalog Number | NF-1004 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B946NF10040 [Primary] |
FDA Product Code
| LXH | Orthopedic Manual Surgical Instrument |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B946NF10040]
Moist Heat or Steam Sterilization
[B946NF10040]
Moist Heat or Steam Sterilization
[B946NF10040]
Moist Heat or Steam Sterilization
[B946NF10040]
Moist Heat or Steam Sterilization
[B946NF10040]
Moist Heat or Steam Sterilization
[B946NF10040]
Moist Heat or Steam Sterilization
[B946NF10040]
Moist Heat or Steam Sterilization
[B946NF10040]
Moist Heat or Steam Sterilization
[B946NF10040]
Moist Heat or Steam Sterilization
[B946NF10040]
Moist Heat or Steam Sterilization
[B946NF10040]
Moist Heat or Steam Sterilization
[B946NF10040]
Moist Heat or Steam Sterilization
[B946NF10040]
Moist Heat or Steam Sterilization
[B946NF10040]
Moist Heat or Steam Sterilization
[B946NF10040]
Moist Heat or Steam Sterilization
[B946NF10040]
Moist Heat or Steam Sterilization
[B946NF10040]
Moist Heat or Steam Sterilization
[B946NF10040]
Moist Heat or Steam Sterilization
[B946NF10040]
Moist Heat or Steam Sterilization
[B946NF10040]
Moist Heat or Steam Sterilization
[B946NF10040]
Moist Heat or Steam Sterilization
[B946NF10040]
Moist Heat or Steam Sterilization
[B946NF10040]
Moist Heat or Steam Sterilization
[B946NF10040]
Moist Heat or Steam Sterilization
[B946NF10040]
Moist Heat or Steam Sterilization
[B946NF10040]
Moist Heat or Steam Sterilization
[B946NF10040]
Moist Heat or Steam Sterilization
[B946NF10040]
Moist Heat or Steam Sterilization
[B946NF10040]
Moist Heat or Steam Sterilization
[B946NF10040]
Moist Heat or Steam Sterilization
[B946NF10040]
Moist Heat or Steam Sterilization
[B946NF10040]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-02 |
| Device Publish Date | 2020-09-24 |
On-Brand Devices [NuFix]
| B946NF10090 | Guide Pins |
| B946NF10070 | 5.0mm Drill Bit |
| B946NF10060 | Carbon Fiber Handle |
| B946NF10050 | NuFix Inserter |
| B946NF10040 | Facet Sound |
| B946NF1003C0 | 4.5mm Drill Bit - Cannulated |
| B946NF10030 | 4.5mm NuFix Drill Bit |
| B946NF1002T0 | Drill Tube |
| B946NF10020 | Drill Guide |
| B946NF1001SC0 | Stainless Steel Facet Locator - Cannulated |
| B946NF1001S0 | Stainless Steel Facet Locator |
| B946NF10010 | Carbon Fiber Facet Locator |
| B946014000010 | 4.5mm NuFix Drill Bit |
Trademark Results [NuFix]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NUFIX 86207226 not registered Dead/Abandoned |
Viatek HK Limited 2014-02-28 |
 NUFIX 77976311 3570762 Live/Registered |
NUTECH SPINE, INC. 2008-02-06 |
 NUFIX 77390360 not registered Dead/Abandoned |
NuFix, Inc. 2008-02-06 |
 NUFIX 73601974 1420715 Dead/Cancelled |
FMC CORPORATION 1986-06-02 |
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