| Primary Device ID | B488830700000 |
| NIH Device Record Key | 26577d1c-151b-4c4b-981b-5c160c8cad87 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NBX |
| Version Model Number | 8307-00-00 |
| Catalog Number | 8307-00-00 |
| Company DUNS | 787238620 |
| Company Name | NUTEK ORTHOPAEDICS 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 | 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(954)779-1400 |
| peter@nutekortho.com | |
| Phone | +1(954)779-1400 |
| peter@nutekortho.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B488830700000 [Primary] |
| KTT | APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[B488830700000]
Radiation Sterilization
[B488830700000]
Radiation Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2018-02-02 |
| B488830700000 | NON-BRIDGING EXTERNAL FIXATOR HAND SHORT |
| B488820700000 | NON-BRIDGING EXTERNAL FIXATOR HAND LONG |
| B488810700000 | NON-BRIDGING EXTERNAL FIXATOR SHOULDER |
| B488800600000 | NON-BRIDGING EXTERNAL FIXATOR WRIST |