| Primary Device ID | B064XMPHCP610081 |
| NIH Device Record Key | 9f92062a-c56d-4d60-b12e-ea63c8d661c4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 8mm One Level Cervical Plate |
| Version Model Number | XM-PH-CP6-1008 |
| Company DUNS | 079282130 |
| Company Name | XENCO MEDICAL LLC |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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 |
|---|---|
| HIBCC | B064XMPHCP610081 [Primary] |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[B064XMPHCP610081]
Radiation Sterilization
[B064XMPHCP610081]
Radiation Sterilization
[B064XMPHCP610081]
Radiation Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-16 |
| Device Publish Date | 2026-02-06 |
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| B064XM3D31225061 - CancelleX™ 15mm x 13mm x 6mm x 12* Cervical Interbody | 2026-02-16 |
| B064XM3D31225071 - CancelleX™ 15mm x 13mm x 7mm x 12* Cervical Interbody | 2026-02-16 |
| B064XM3D31225081 - CancelleX™ 15mm x 13mm x 8mm x 12* Cervical Interbody | 2026-02-16 |
| B064XMPHCP610081 - 8mm One Level Cervical Plate | 2026-02-16 |
| B064XMPHCP610081 - 8mm One Level Cervical Plate | 2026-02-16 |
| B064HB11200101 - Tube Guard | 2023-08-15 |
| B064MPE010101 - Saratoga Cervical Brace | 2023-08-15 |
| B064MPE010401 - Tahiti Lumbar Brace | 2023-08-15 |