| Primary Device ID | 00840606181839 |
| NIH Device Record Key | 8315f29b-ac96-4f96-ae38-ec8eff3d4a2a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ventana C |
| Version Model Number | 40021-701 |
| Company DUNS | 610712213 |
| Company Name | SPINAL ELEMENTS, 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840606181839 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840606181839]
Moist Heat or Steam Sterilization
[00840606181839]
Moist Heat or Steam Sterilization
[00840606181839]
Moist Heat or Steam Sterilization
[00840606181839]
Moist Heat or Steam Sterilization
[00840606181839]
Moist Heat or Steam Sterilization
[00840606181839]
Moist Heat or Steam Sterilization
[00840606181839]
Moist Heat or Steam Sterilization
[00840606181839]
Moist Heat or Steam Sterilization
[00840606181839]
Moist Heat or Steam Sterilization
[00840606181839]
Moist Heat or Steam Sterilization
[00840606181839]
Moist Heat or Steam Sterilization
[00840606181839]
Moist Heat or Steam Sterilization
[00840606181839]
Moist Heat or Steam Sterilization
[00840606181839]
Moist Heat or Steam Sterilization
[00840606181839]
Moist Heat or Steam Sterilization
[00840606181839]
Moist Heat or Steam Sterilization
[00840606181839]
Moist Heat or Steam Sterilization
[00840606181839]
Moist Heat or Steam Sterilization
[00840606181839]
Moist Heat or Steam Sterilization
[00840606181839]
Moist Heat or Steam Sterilization
[00840606181839]
Moist Heat or Steam Sterilization
[00840606181839]
Moist Heat or Steam Sterilization
[00840606181839]
Moist Heat or Steam Sterilization
[00840606181839]
Moist Heat or Steam Sterilization
[00840606181839]
Moist Heat or Steam Sterilization
[00840606181839]
Moist Heat or Steam Sterilization
[00840606181839]
Moist Heat or Steam Sterilization
[00840606181839]
Moist Heat or Steam Sterilization
[00840606181839]
Moist Heat or Steam Sterilization
[00840606181839]
Moist Heat or Steam Sterilization
[00840606181839]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-05 |
| Device Publish Date | 2023-08-28 |
| 00840606175791 | Ventana™ C 14mm x 11mm 7° Caddy Assembly |
| 00840606181860 | CERVICAL 20MM X 16MM, 7° DUAL TRIAL, NO STOP15MM/12MM RASP |
| 00840606181853 | CERVICAL 20MM X 16MM, 7° DUAL TRIAL, NO STOP9MM/10MM RASP |
| 00840606181846 | CERVICAL 20MM X 16MM, 7° DUAL TRIAL, NO STOP7MM/8MM RASP |
| 00840606181839 | CERVICAL 20MM X 16MM, 7° DUAL TRIAL, NO STOP4MM/6MM RASP |
| 00840606181822 | CERVICAL 20MM X 16MM, 7° DUAL TRIAL, NO STOP15MM/12MM |
| 00840606181815 | CERVICAL 20MM X 16MM, 7° DUAL TRIAL, NO STOP9MM/10MM |
| 00840606181808 | CERVICAL 20MM X 16MM, 7° DUAL TRIAL, NO STOP7MM/8MM |
| 00840606181792 | CERVICAL 20MM X 16MM, 7° DUAL TRIAL, NO STOP4MM/6MM |
| 00840606181785 | CERVICAL 18MM X 15MM, 7° DUAL TRIAL, NO STOP15MM/12MM RASP |
| 00840606181778 | CERVICAL 18MM X 15MM, 7° DUAL TRIAL, NO STOP9MM/10MM RASP |
| 00840606181761 | CERVICAL 18MM X 15MM, 7° DUAL TRIAL, NO STOP7MM/8MM RASP |
| 00840606181754 | CERVICAL 18MM X 15MM, 7° DUAL TRIAL, NO STOP 4MM/6MM RASP |
| 00840606181747 | CERVICAL 18MM X 15MM, 7° DUAL TRIAL, NO STOP15MM/12MM |
| 00840606181730 | CERVICAL 18MM X 15MM, 7° DUAL TRIAL, NO STOP9MM/10MM |
| 00840606181723 | CERVICAL 18MM X 15MM, 7° DUAL TRIAL, NO STOP7MM/8MM |
| 00840606181716 | CERVICAL 18MM X 15MM, 7° DUAL TRIAL, NO STOP4MM/6MM |
| 00840606181587 | VENTANA™ C CADDY, LID, LARGE |
| 00840606181570 | 20MM X 16MM 12° CADDY, BASE |
| 00840606181563 | VENTANA™ C 20MM X 16MM 12° CADDY ASSEMBLY |
| 00840606181556 | 16MM X 13MM 12° CADDY, BASE |
| 00840606181549 | VENTANA™ C 16MM X 13MM 12° CADDY ASSEMBLY |
| 00840606181532 | VENTANA™ C CADDY, LID, SMALL |
| 00840606181525 | 14MM X 11MM 12° CADDY, BASE |
| 00840606181518 | VENTANA™ C 14MM X 11MM 12° CADDY ASSEMBLY |
| 00840606181501 | CERVICAL INSERTER, BODY,LONG SHAFT, LARGE KNOB |
| 00840606181495 | CERVICAL INSERTER, BODY,MEDIUM SHAFT, LARGE KNOB |
| 00840606181488 | CERVICAL INSERTER, BODY,SHORT SHAFT, LARGE, KNOB |
| 00840606181471 | CERVICAL INSERTER, BODY,LONG SHAFT, SMALL KNOB |
| 00840606181464 | CERVICAL INSERTER, BODY,MEDIUM SHAFT, SMALL KNOB |
| 00840606181457 | CERVICAL INSERTER, BODY,SHORT SHAFT, SMALL KNOB |
| 00840606181440 | CERVICAL INSERTER, INTERNAL SHAFT,LONG SHAFT, LARGE KNOB |
| 00840606181433 | CERVICAL INSERTER, INTERNAL SHAFT,MEDIUM SHAFT, LARGE KNOB |
| 00840606181426 | CERVICAL INSERTER, INTERNAL SHAFT,SHORT SHAFT, LARGE, KNOB |
| 00840606181419 | CERVICAL INSERTER, INTERNAL SHAFT,LONG SHAFT, SMALL KNOB |
| 00840606181402 | CERVICAL INSERTER, INTERNAL SHAFT,MEDIUM SHAFT, SMALL KNOB |
| 00840606181396 | CERVICAL INSERTER, INTERNAL SHAFT,SHORT SHAFT, SMALL KNOB |
| 00840606181389 | 20MM X 16MM 7° CADDY, BASE |
| 00840606181372 | VENTANA™ C 20MM X 16MM 7° CADDY ASSEMBLY |
| 00840606181365 | 18MM X 15MM 7° CADDY, BASE |
| 00840606181358 | VENTANA™ C 18MM X 15MM 7° CADDY ASSEMBLY |
| 00840606181334 | 18MM X 15MM 12° CADDY, BASE |
| 00840606181327 | VENTANA™ C 18MM X 15MM 12° CADDY ASSEMBLY |
| 00840606181228 | 20MM X 14MM X 12MM 14°VENTANA™ C CERVICAL INTERBODY |
| 00840606181211 | 20MM X 14MM X 11MM 14°VENTANA™ C CERVICAL INTERBODY |
| 00840606181204 | 20MM X 14MM X 10MM 14°VENTANA™ C CERVICAL INTERBODY |
| 00840606181198 | 20MM X 14MM X 9MM 14°VENTANA™ C CERVICAL INTERBODY |
| 00840606181181 | 20MM X 14MM X 8MM 14°VENTANA™ C CERVICAL INTERBODY |
| 00840606181174 | 20MM X 14MM X 7MM 14°VENTANA™ C CERVICAL INTERBODY |
| 00840606181167 | 20MM X 14MM X 12MM 12°VENTANA™ C CERVICAL INTERBODY |