| Primary Device ID | M719GCV100XS0 |
| NIH Device Record Key | c861a08d-eaa5-445e-9ae0-a54faf2e9191 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Apache Anchored Cervical |
| Version Model Number | 1 |
| Catalog Number | GCV100-XS |
| Company DUNS | 017921066 |
| Company Name | Genesys Orthopedics Systems 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M719GCV100XS0 [Primary] |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M719GCV100XS0]
Moist Heat or Steam Sterilization
[M719GCV100XS0]
Moist Heat or Steam Sterilization
[M719GCV100XS0]
Moist Heat or Steam Sterilization
[M719GCV100XS0]
Moist Heat or Steam Sterilization
[M719GCV100XS0]
Moist Heat or Steam Sterilization
[M719GCV100XS0]
Moist Heat or Steam Sterilization
[M719GCV100XS0]
Moist Heat or Steam Sterilization
[M719GCV100XS0]
Moist Heat or Steam Sterilization
[M719GCV100XS0]
Moist Heat or Steam Sterilization
[M719GCV100XS0]
Moist Heat or Steam Sterilization
[M719GCV100XS0]
Moist Heat or Steam Sterilization
[M719GCV100XS0]
Moist Heat or Steam Sterilization
[M719GCV100XS0]
Moist Heat or Steam Sterilization
[M719GCV100XS0]
Moist Heat or Steam Sterilization
[M719GCV100XS0]
Moist Heat or Steam Sterilization
[M719GCV100XS0]
Moist Heat or Steam Sterilization
[M719GCV100XS0]
Moist Heat or Steam Sterilization
[M719GCV100XS0]
Moist Heat or Steam Sterilization
[M719GCV100XS0]
Moist Heat or Steam Sterilization
[M719GCV100XS0]
Moist Heat or Steam Sterilization
[M719GCV100XS0]
Moist Heat or Steam Sterilization
[M719GCV100XS0]
Moist Heat or Steam Sterilization
[M719GCV100XS0]
Moist Heat or Steam Sterilization
[M719GCV100XS0]
Moist Heat or Steam Sterilization
[M719GCV100XS0]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-09-30 |
| Device Publish Date | 2021-09-22 |
| M719GCV100XS0 | AIS-C Extra Small Inserter |
| M719GCV1140 | Fixed Stop Anchor Finisher |