| Primary Device ID | M697N600010821 |
| NIH Device Record Key | 47f71823-3fd5-4961-a0c0-f0d6c11c4732 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | X90 Pedicle Screw System |
| Version Model Number | N60001082 |
| Company DUNS | 081224143 |
| Company Name | Xtant Medical Holdings, Inc. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 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(937)847-8400 |
| orders@x-spine.com | |
| Phone | +1(937)847-8400 |
| orders@x-spine.com | |
| Phone | +1(937)847-8400 |
| orders@x-spine.com | |
| Phone | +1(937)847-8400 |
| orders@x-spine.com | |
| Phone | +1(937)847-8400 |
| orders@x-spine.com | |
| Phone | +1(937)847-8400 |
| orders@x-spine.com | |
| Phone | +1(937)847-8400 |
| orders@x-spine.com | |
| Phone | +1(937)847-8400 |
| orders@x-spine.com | |
| Phone | +1(937)847-8400 |
| orders@x-spine.com | |
| Phone | +1(937)847-8400 |
| orders@x-spine.com | |
| Phone | +1(937)847-8400 |
| orders@x-spine.com | |
| Phone | +1(937)847-8400 |
| orders@x-spine.com | |
| Phone | +1(937)847-8400 |
| orders@x-spine.com | |
| Phone | +1(937)847-8400 |
| orders@x-spine.com | |
| Phone | +1(937)847-8400 |
| orders@x-spine.com |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M697N600010821 [Primary] |
| MNI | ORTHOSIS, SPINAL PEDICLE FIXATION |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M697N600010821]
Moist Heat or Steam Sterilization
[M697N600010821]
Moist Heat or Steam Sterilization
[M697N600010821]
Moist Heat or Steam Sterilization
[M697N600010821]
Moist Heat or Steam Sterilization
[M697N600010821]
Moist Heat or Steam Sterilization
[M697N600010821]
Moist Heat or Steam Sterilization
[M697N600010821]
Moist Heat or Steam Sterilization
[M697N600010821]
Moist Heat or Steam Sterilization
[M697N600010821]
Moist Heat or Steam Sterilization
[M697N600010821]
Moist Heat or Steam Sterilization
[M697N600010821]
Moist Heat or Steam Sterilization
[M697N600010821]
Moist Heat or Steam Sterilization
[M697N600010821]
Moist Heat or Steam Sterilization
[M697N600010821]
Moist Heat or Steam Sterilization
[M697N600010821]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2021-06-03 |
| Device Publish Date | 2015-09-28 |
| M697N607555SDDL1 | Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 7.5 x 55 |
| M697N607555SD1 | Assembly, X90, 7.5 x 55 Self-Drilling Screw |
| M697N607550SDDL1 | Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 7.5 x 50 |
| M697N607550SD1 | Assembly, X90, 7.5 x 50 Self-Drilling Screw |
| M697N607545SDDL1 | Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 7.5 x 45 |
| M697N607545SD1 | Assembly, X90, 7.5 x 45 Self-Drilling Screw |
| M697N607540SDDL1 | Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 7.5 x 40 |
| M697N607540SD1 | Assembly, X90, 7.5 x 40 Self-Drilling Screw |
| M697N607535SDDL1 | Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 7.5 x 35 |
| M697N607535SD1 | Assembly, X90, 7.5 x 35 Self-Drilling Screw |
| M697N607530SDDL1 | Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 7.5 x 30 |
| M697N607530SD1 | Assembly, X90, 7.5 x 30 Self-Drilling Screw |
| M697N606555SDDL1 | Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 6.5 x 55 |
| M697N606555SD1 | Assembly, X90, 6.5 x 55 Self-Drilling Screw |
| M697N606550SDDL1 | Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 6.5 x 50 |
| M697N606550SD1 | Assembly, X90, 6.5 x 50 Self-Drilling Screw |
| M697N606545SDDL1 | Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 6.5 x 45 |
| M697N606545SD1 | Assembly, X90, 6.5 x 45 Self-Drilling Screw |
| M697N606540SDDL1 | Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 6.5 x 40 |
| M697N606540SD1 | Assembly, X90, 6.5 x 40 Self-Drilling Screw |
| M697N606535SDDL1 | Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 6.5 x 35 |
| M697N606535SD1 | Assembly, X90, 6.5 x 35 Self-Drilling Screw |
| M697N606530SDDL1 | Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 6.5 x 30 |
| M697N606530SD1 | Assembly, X90, 6.5 x 30 Self-Drilling Screw |
| M697N605555SDDL1 | Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 5.5 x 55 |
| M697N605555SD1 | Assembly, X90, 5.5 x 55 Self-Drilling Screw |
| M697N605550SDDL1 | Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 5.5 x 50 |
| M697N605550SD1 | Assembly, X90, 5.5 x 50 Self-Drilling Screw |
| M697N605545SDDL1 | Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 5.5 x 45 |
| M697N605545SD1 | Assembly, X90, 5.5 x 45 Self-Drilling Screw |
| M697N605540SDDL1 | Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 5.5 x 40 |
| M697N605540SD1 | Assembly, X90, 5.5 x 40 Self-Drilling Screw |
| M697N605535SDDL1 | Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 5.5 x 35 |
| M697N605535SD1 | Assembly, X90, 5.5 x 35 Self-Drilling Screw |
| M697N605530SDDL1 | Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 5.5 x 30 |
| M697N605530SD1 | Assembly, X90, 5.5 x 30 Self-Drilling Screw |
| M697N600022010 | Sterilization Case, 5.5mm Rod, Instrument |
| M697N600022000 | 5.5mm Rod Instrument Set |
| M697N600021050 | Cross Connector Caddy, X90 |
| M697N600021040 | Rod Caddy, X90 |
| M697N600021030 | Sterilization Case, X90, Instrument |
| M697N600021020 | Sterilization Case, X90, Implant |
| M697N600016200 | Twist Driver, Assembly |
| M697N600016100 | Flex Locking Screwdriver, X90, Assy |
| M697N600015780 | CAM SCREWDRIVER THUMB WHEEL |
| M697N600015770 | CAM SCREWDRIVER FORK SLEEVE |
| M697N600015760 | CAM SCREWDRIVER HEX SHAFT |
| M697N600015750 | CAM SCREWDRIVER ASSEMBLY |
| M697N600015540 | FINAL LOCKING WRENCH, 1/4" SQUARE |
| M697N600015530 | PROVISIONAL LOCKING WRENCH, 1/4" SQUARE |