Primary Device ID | 00840606161534 |
NIH Device Record Key | d71d8845-f2b0-45cb-ab22-d412b924093b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Sapphire X |
Version Model Number | 27000-000-09 |
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 | 00840606161534 [Primary] |
OJH | Orthopedic Tray |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
[00840606161534]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-09-14 |
Device Publish Date | 2020-09-04 |
00840606160438 | SAPPHIRE X, AWL-DRILL SLEEVE CAP |
00840606160421 | SAPPHIRE X, AWL-DRILL SLEEVE |
00840606160414 | SAPPHRIE X, 10MM AWL |
00840606160407 | SAPPHIRE X, AWL-DRILL, TRIPLE FLUTE Ø2.0 X 18MM |
00840606160391 | SAPPHIRE X, AWL-DRILL, TRIPLE FLUTE Ø2.0 X 16MM |
00840606160384 | SAPPHIRE X, AWL-DRILL, TRIPLE FLUTE Ø2.0 X 14MM |
00840606160377 | SAPPHIRE X, AWL-DRILL, TRIPLE FLUTE Ø2.0 X 12MM |
00840606160360 | SAPPHIRE X, AWL-DRILL, DOUBLE FLUTE Ø2.0 X 10MM |
00840606160353 | SAPPHIRE X, AWL-DRILL, DOUBLE FLUTE Ø2.0 X 18MM |
00840606160346 | SAPPHIRE X, AWL-DRILL, DOUBLE FLUTE Ø2.0 X 16MM |
00840606160339 | SAPPHIRE X, AWL-DRILL, DOUBLE FLUTE Ø2.0 X 14MM |
00840606160322 | SAPPHIRE X, AWL-DRILL, DOUBLE FLUTE Ø2.0 X 12MM |
00840606160315 | SAPPHIRE X, AWL-DRILL, DOUBLE FLUTE Ø2.0 X 10MM |
00840606151344 | Sapphire X Fixed Drill Guide 60° |
00840606151337 | Sapphire X Fixed Drill Guide 45° |
00840606151320 | Sapphire X Fixed Drill Guide 30° |
00840606151313 | Sapphire X Fixed Drill Guide 15° |
00840606160773 | 1-Level Sapphire X Cervical Plate, 20mm |
00840606159982 | 1-Level Sapphire X Cervical Plate, 18mm |
00840606159975 | 1-Level Sapphire X Cervical Plate, 16mm |
00840606159968 | 1-Level Sapphire X Cervical Plate, 14mm |
00840606159951 | 1-Level Sapphire X Cervical Plate, 13mm |
00840606159944 | 1-Level Sapphire X Cervical Plate, 12mm |
00840606159937 | 1-Level Sapphire X Cervical Plate, 11mm |
00840606159920 | 1-Level Sapphire X Cervical Plate, 10mm |
00840606159913 | 1-Level Sapphire X Cervical Plate, 9mm |
00840606159906 | 1-Level Sapphire X Cervical Plate, 8mm |
00840606161695 | SAPPHIRE X FIXED ANGLE SCREW, CADDY, LID |
00840606161688 | SAPPHIRE X FIXED ANGLE SCREW, CADDY, BASE |
00840606161671 | SAPPHIRE X FIXED ANGLE SCREW, CADDY ASSEMBLY |
00840606161664 | SAPPHIRE X 1-LEVEL PLATE, CADDY, LID |
00840606161657 | SAPPHIRE X 1-LEVEL PLATE, CADDY, BASE |
00840606161640 | SAPPHIRE X 1-LEVEL PLATE, CADDY ASSEMBLY |
00840606161633 | SAPPHIRE X VARIABLE ANGLE SCREW, CADDY, LID |
00840606161626 | SAPPHIRE X VARIABLE ANGLE SCREW, CADDY, BASE |
00840606161619 | SAPPHIRE X VARIABLE ANGLE SCREW, CADDY ASSEMBLY |
00840606161602 | 16MM X 13MM 7° TI-BOND INTERBODY CAGE, CADDY, LID |
00840606161596 | 16MM X 13MM 7° TI-BOND INTERBODY CAGE, CADDY, BASE |
00840606161589 | 16MM X 13MM 7° TI-BOND INTERBODY CAGE, CADDY ASSEMBLY |
00840606161572 | 14MM X 11MM 7° TI-BOND INTERBODY CAGE, CADDY, LID |
00840606161565 | 14MM X 11MM 7° TI-BOND INTERBODY CAGE, CADDY, BASE |
00840606161558 | 14MM X 11MM 7° TI-BOND INTERBODY CAGE, CADDY ASSEMBLY |
00840606161541 | SAPPHIRE X IMPLANT & INSTRUMENT TRAY, CADDY INSERT |
00840606161534 | SAPPHIRE X IMPLANT & INSTRUMENT TRAY, INSTRUMENT INSERT |
00840606161527 | SAPPHIRE X IMPLANT & INSTRUMENT TRAY, LID |
00840606161510 | SAPPHIRE X IMPLANT & INSTRUMENT TRAY, BASE |
00840606161503 | SAPPHIRE X IMPLANT & INSTRUMENT TRAY, ASSEMBLY |
00840606163552 | 2-LEVEL SAPPHIRE X™ CERVICAL PLATE, 34MM |
00840606163545 | 2-LEVEL SAPPHIRE X™ CERVICAL PLATE, 32MM |
00840606163538 | 2-LEVEL SAPPHIRE X™ CERVICAL PLATE, 30MM |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SAPPHIRE X 90034017 not registered Live/Pending |
Spinal Elements, Inc. 2020-07-02 |