| Primary Device ID | 00613994641663 |
| NIH Device Record Key | 38b387f9-532e-486f-8169-f3ac7c29df4b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Vertex Reconstruction System |
| Version Model Number | G7750015 |
| Company DUNS | 830350380 |
| Company Name | MEDTRONIC SOFAMOR DANEK, INC. |
| Device Count | 1 |
| DM Exempt | false |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994641663 [Primary] |
| KWP | APPLIANCE, FIXATION, SPINAL INTERLAMINAL |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00613994641663]
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[00613994641663]
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[00613994641663]
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[00613994641663]
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[00613994641663]
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[00613994641663]
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[00613994641663]
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[00613994641663]
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[00613994641663]
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[00613994641663]
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[00613994641663]
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[00613994641663]
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[00613994641663]
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[00613994641663]
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[00613994641663]
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[00613994641663]
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[00613994641663]
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[00613994641663]
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[00613994641663]
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[00613994641663]
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[00613994641663]
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[00613994641663]
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[00613994641663]
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[00613994641663]
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[00613994641663]
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[00613994641663]
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[00613994641663]
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[00613994641663]
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[00613994641663]
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[00613994641663]
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[00613994641663]
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[00613994641663]
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[00613994641663]
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[00613994641663]
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[00613994641663]
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[00613994641663]
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[00613994641663]
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[00613994641663]
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[00613994641663]
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[00613994641663]
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[00613994641663]
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[00613994641663]
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[00613994641663]
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| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-09-27 |
| Device Publish Date | 2021-09-18 |
| 00613994666987 | ROD G7755274 PRE-BENT CCM 3.5 X 100MM |
| 00613994666970 | ROD G7755275 PRE-BENT CCM 3.5 X 200MM |
| 00613994666642 | ROD G7755270 PRE-BENT 3.5 X 100MM |
| 00613994641908 | ROD G7750087 COBALT CHROME 3.5 X 240MM |
| 00613994641892 | ROD G7750086 COBALT CHROME 3.5 X 120MM |
| 00613994641670 | ROD G7750020 TI 3.5 X 300MM |
| 00613994641663 | ROD G7750015 TI 3.5 X 240MM |
| 00613994641656 | ROD G7750010 TI 3.5 X 120MM |