| Primary Device ID | M697C08001080 |
| NIH Device Record Key | 5f269451-a110-4fb7-99ff-23df2987add9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Irix-A Lumbar Integrated Fusion System |
| Version Model Number | C080-0108 |
| Company DUNS | 610042587 |
| Company Name | X-SPINE SYSTEMS, 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 | 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(888)886-9354 |
| cs@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| cs@xtantmedical.com | |
| Phone | +1(888)886-9354 |
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| Phone | +1(888)886-9354 |
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| Phone | +1(888)886-9354 |
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| Phone | +1(888)886-9354 |
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| Phone | +1(888)886-9354 |
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| Phone | +1(888)886-9354 |
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| Phone | +1(888)886-9354 |
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| Phone | +1(888)886-9354 |
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| Phone | +1(888)886-9354 |
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| Phone | +1(888)886-9354 |
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| Phone | +1(888)886-9354 |
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| Phone | +1(888)886-9354 |
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| Phone | +1(888)886-9354 |
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| Phone | +1(888)886-9354 |
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| Phone | +1(888)886-9354 |
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| Phone | +1(888)886-9354 |
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| Phone | +1(888)886-9354 |
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| Phone | +1(888)886-9354 |
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| Phone | +1(888)886-9354 |
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| Phone | +1(888)886-9354 |
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| Phone | +1(888)886-9354 |
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| Phone | +1(888)886-9354 |
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| Phone | +1(888)886-9354 |
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| Phone | +1(888)886-9354 |
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| Phone | +1(888)886-9354 |
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| Phone | +1(888)886-9354 |
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| Phone | +1(888)886-9354 |
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| Phone | +1(888)886-9354 |
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| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M697C08001080 [Direct Marking] |
| HIBCC | M697C08001081 [Primary] |
| HXX | Screwdriver |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M697C08001080]
Moist Heat or Steam Sterilization
[M697C08001080]
Moist Heat or Steam Sterilization
[M697C08001080]
Moist Heat or Steam Sterilization
[M697C08001080]
Moist Heat or Steam Sterilization
[M697C08001080]
Moist Heat or Steam Sterilization
[M697C08001080]
Moist Heat or Steam Sterilization
[M697C08001080]
Moist Heat or Steam Sterilization
[M697C08001080]
Moist Heat or Steam Sterilization
[M697C08001080]
Moist Heat or Steam Sterilization
[M697C08001080]
Moist Heat or Steam Sterilization
[M697C08001080]
Moist Heat or Steam Sterilization
[M697C08001080]
Moist Heat or Steam Sterilization
[M697C08001080]
Moist Heat or Steam Sterilization
[M697C08001080]
Moist Heat or Steam Sterilization
[M697C08001080]
Moist Heat or Steam Sterilization
[M697C08001080]
Moist Heat or Steam Sterilization
[M697C08001080]
Moist Heat or Steam Sterilization
[M697C08001080]
Moist Heat or Steam Sterilization
[M697C08001080]
Moist Heat or Steam Sterilization
[M697C08001080]
Moist Heat or Steam Sterilization
[M697C08001080]
Moist Heat or Steam Sterilization
[M697C08001080]
Moist Heat or Steam Sterilization
[M697C08001080]
Moist Heat or Steam Sterilization
[M697C08001080]
Moist Heat or Steam Sterilization
[M697C08001080]
Moist Heat or Steam Sterilization
[M697C08001080]
Moist Heat or Steam Sterilization
[M697C08001080]
Moist Heat or Steam Sterilization
[M697C08001080]
Moist Heat or Steam Sterilization
[M697C08001080]
Moist Heat or Steam Sterilization
[M697C08001080]
Moist Heat or Steam Sterilization
[M697C08001080]
Moist Heat or Steam Sterilization
[M697C08001080]
Moist Heat or Steam Sterilization
[M697C08001080]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-11-13 |
| Device Publish Date | 2019-11-05 |
| M697C08001080 | Irix-A Smooth shaft Universal Joint Driver |
| M697C08001070 | Irix-A Smooth Driver |
| M697X08042301924TSTR1 | IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 24°, 19mm (STERILE) |
| M697X08042301920TSTR1 | IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 20°, 19mm (STERILE) |
| M697X08042301916TSTR1 | IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 16°, 19mm (STERILE) |
| M697X08042301724TSTR1 | IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 24°, 17mm (STERILE) |
| M697X08042301720TSTR1 | IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 20°, 17mm (STERILE) |
| M697X08042301716TSTR1 | IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 16°, 17mm (STERILE) |
| M697X08042301524TSTR1 | IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 24°, 15mm (STERILE) |
| M697X08042301520TSTR1 | IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 20°, 15mm (STERILE) |
| M697X08042301516TSTR1 | IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 16°, 15mm (STERILE) |
| M697X08042301320TSTR1 | IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 20°, 13mm (STERILE) |
| M697X08042301316TSTR1 | IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 16°, 13mm (STERILE) |
| M697X08042301116TSTR1 | IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 16°, 11mm (STERILE) |
| M697X08038281924TSTR1 | IRIX-A INTEGRATED SPACER, TITANIUM, 38 X 28 X 24°, 19mm (STERILE) |
| M697X08038281920TSTR1 | IRIX-A INTEGRATED SPACER, TITANIUM, 38 X 28 X 20°, 19mm (STERILE) |
| M697X08038281916TSTR1 | IRIX-A INTEGRATED SPACER, TITANIUM, 38 X 28 X 16°, 19mm (STERILE) |
| M697X08038281724TSTR1 | IRIX-A INTEGRATED SPACER, TITANIUM, 38 X 28 X 24°, 17mm (STERILE) |
| M697X08038281720TSTR1 | IRIX-A INTEGRATED SPACER, TITANIUM, 38 X 28 X 20°, 17mm (STERILE) |
| M697X08038281716TSTR1 | IRIX-A INTEGRATED SPACER, TITANIUM, 38 X 28 X 16°, 17mm (STERILE) |
| M697X08038281524TSTR1 | IRIX-A INTEGRATED SPACER, TITANIUM, 38 X 28 X 24°, 15mm (STERILE) |
| M697X08038281520TSTR1 | IRIX-A INTEGRATED SPACER, TITANIUM, 38 X 28 X 20°, 15mm (STERILE) |
| M697X08038281516TSTR1 | IRIX-A INTEGRATED SPACER, TITANIUM, 38 X 28 X 16°, 15mm (STERILE) |
| M697X08038281320TSTR1 | IRIX-A INTEGRATED SPACER, TITANIUM, 38 X 28 X 20°, 13mm (STERILE) |
| M697X08038281316TSTR1 | IRIX-A INTEGRATED SPACER, TITANIUM, 38 X 28 X 16°, 13mm (STERILE) |
| M697X08038281116TSTR1 | IRIX-A INTEGRATED SPACER, TITANIUM, 38 X 28 X 16°, 11mm (STERILE) |
| M697X08033261924TSTR1 | IRIX-A INTEGRATED SPACER, TITANIUM, 33 X 26 X 24°, 19mm (STERILE) |
| M697X08033261920TSTR1 | IRIX-A INTEGRATED SPACER, TITANIUM, 33 X 26 X 20°, 19mm (STERILE) |
| M697X08033261916TSTR1 | IRIX-A INTEGRATED SPACER, TITANIUM, 33 X 26 X 16°, 19mm (STERILE) |
| M697X08033261724TSTR1 | IRIX-A INTEGRATED SPACER, TITANIUM, 33 X 26 X 24°, 17mm (STERILE) |
| M697X08033261720TSTR1 | IRIX-A INTEGRATED SPACER, TITANIUM, 33 X 26 X 20°, 17mm (STERILE) |
| M697X08033261716TSTR1 | IRIX-A INTEGRATED SPACER, TITANIUM, 33 X 26 X 16°, 17mm (STERILE) |
| M697X08033261524TSTR1 | IRIX-A INTEGRATED SPACER, TITANIUM, 33 X 26 X 24°, 15mm (STERILE) |
| M697X08033261520TSTR1 | IRIX-A INTEGRATED SPACER, TITANIUM, 33 X 26 X 20°, 15mm (STERILE) |
| M697X08033261516TSTR1 | IRIX-A INTEGRATED SPACER, TITANIUM, 33 X 26 X 16°, 15mm (STERILE) |
| M697X08033261324TSTR1 | IRIX-A INTEGRATED SPACER, TITANIUM, 33 X 26 X 24°, 13mm (STERILE) |
| M697X08033261320TSTR1 | IRIX-A INTEGRATED SPACER, TITANIUM, 33 X 26 X 20°, 13mm (STERILE) |
| M697X08033261316TSTR1 | IRIX-A INTEGRATED SPACER, TITANIUM, 33 X 26 X 16°, 13mm (STERILE) |
| M697X08033261120TSTR1 | IRIX-A INTEGRATED SPACER, TITANIUM, 33 X 26 X 20°, 11mm (STERILE) |
| M697X08033261116TSTR1 | IRIX-A INTEGRATED SPACER, TITANIUM, 33 X 26 X 16°, 11mm (STERILE) |
| M697C0804230190 | 423019 GUIDED INSERTER, ASSEMBLY |
| M697C0804230170 | 423017 GUIDED INSERTER, ASSEMBLY |
| M697C0804230150 | 423015 GUIDED INSERTER, ASSEMBLY |
| M697C0804230130 | 423013 GUIDED INSERTER, ASSEMBLY |
| M697C0804230110 | 423011 GUIDED INSERTER, ASSEMBLY |
| M697C0803828190 | 382819 GUIDED INSERTER, ASSEMBLY |
| M697C0803828150 | 382815 GUIDED INSERTER, ASSEMBLY |
| M697C0803828130 | 382813 GUIDED INSERTER, ASSEMBLY |
| M697C0803828110 | 382811 GUIDED INSERTER, ASSEMBLY |
| M697C0803326190 | 332619 GUIDED INSERTER, ASSEMBLY |