| Primary Device ID | 00857360007015 |
| NIH Device Record Key | 11c5b129-7792-40c8-8168-203a085b4d19 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Decima Spine Instrument Kit |
| Version Model Number | 6079 |
| Catalog Number | 6079 |
| Company DUNS | 080963983 |
| Company Name | DECIMA SPINE, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | +1 (954) 243-6103 |
| carlos@decimaspine.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00857360007015 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00857360007015]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-08-09 |
| Device Publish Date | 2018-04-04 |
| 00857360007220 | FCD-2 Removal Kit |
| 00857360007213 | FCD-2 Stabilizer Removal Tool |
| 00857360007206 | FCD-2 Removal Cassette Assembly |
| 00857360007145 | Decima Spine Instrument Kit |
| 00857360007138 | Decima Spine Instrument Kit, Tray Assembly |
| 00857360007114 | Cassette Assembly |
| 00857360007107 | Slap Hammer |
| 00857360007091 | Tap |
| 00857360007084 | Pre-Drill |
| 00857360007077 | REMOVAL DRIVER |
| 00857360007060 | INSERTION TOOL |
| 00857360007053 | Driver |
| 00857360007046 | Countersink |
| 00857360007039 | 11mm Deciport |
| 00857360007015 | Quick Release Handle |
| 00857360007008 | Kichner Wire |