| Primary Device ID | M719SEC80605L0 |
| NIH Device Record Key | f337d38d-08f8-4b51-8706-64b9a3bcf017 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 3DP AIS-C II Cervical Interbody System |
| Version Model Number | 1 |
| Catalog Number | SEC806-05L |
| 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 | 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 | 5123817070 |
| info@genesysspine.com | |
| Phone | 5123817070 |
| info@genesysspine.com | |
| Phone | 5123817070 |
| info@genesysspine.com | |
| Phone | 5123817070 |
| info@genesysspine.com | |
| Phone | 5123817070 |
| info@genesysspine.com | |
| Phone | 5123817070 |
| info@genesysspine.com | |
| Phone | 5123817070 |
| info@genesysspine.com | |
| Phone | 5123817070 |
| info@genesysspine.com | |
| Phone | 5123817070 |
| info@genesysspine.com | |
| Phone | 5123817070 |
| info@genesysspine.com | |
| Phone | 5123817070 |
| info@genesysspine.com | |
| Phone | 5123817070 |
| info@genesysspine.com | |
| Phone | 5123817070 |
| info@genesysspine.com | |
| Phone | 5123817070 |
| info@genesysspine.com | |
| Phone | 5123817070 |
| info@genesysspine.com |
| Height | 9 Millimeter |
| Height | 9 Millimeter |
| Height | 9 Millimeter |
| Height | 9 Millimeter |
| Height | 9 Millimeter |
| Height | 9 Millimeter |
| Height | 9 Millimeter |
| Height | 9 Millimeter |
| Height | 9 Millimeter |
| Height | 9 Millimeter |
| Height | 9 Millimeter |
| Height | 9 Millimeter |
| Height | 9 Millimeter |
| Height | 9 Millimeter |
| Height | 9 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M719SEC80605L0 [Primary] |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M719SEC80605L0]
Moist Heat or Steam Sterilization
[M719SEC80605L0]
Moist Heat or Steam Sterilization
[M719SEC80605L0]
Moist Heat or Steam Sterilization
[M719SEC80605L0]
Moist Heat or Steam Sterilization
[M719SEC80605L0]
Moist Heat or Steam Sterilization
[M719SEC80605L0]
Moist Heat or Steam Sterilization
[M719SEC80605L0]
Moist Heat or Steam Sterilization
[M719SEC80605L0]
Moist Heat or Steam Sterilization
[M719SEC80605L0]
Moist Heat or Steam Sterilization
[M719SEC80605L0]
Moist Heat or Steam Sterilization
[M719SEC80605L0]
Moist Heat or Steam Sterilization
[M719SEC80605L0]
Moist Heat or Steam Sterilization
[M719SEC80605L0]
Moist Heat or Steam Sterilization
[M719SEC80605L0]
Moist Heat or Steam Sterilization
[M719SEC80605L0]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-12 |
| Device Publish Date | 2024-03-04 |
| M719SEC80712L0 | Stryker 12 mm AIS-C II Cervical-SA, Large, 3DP Convex Interbody |
| M719SEC80711S0 | Stryker 11 mm AIS-C II Cervical-SA, Small, 3DP Convex Interbody |
| M719SEC80711L0 | Stryker 11 mm AIS-C II Cervical-SA, Large, 3DP Convex Interbody |
| M719SEC80710S0 | Stryker 10 mm AIS-C II Cervical-SA, Small, 3DP Convex Interbody |
| M719SEC80710L0 | Stryker 10 mm AIS-C II Cervical-SA, Large, 3DP Convex Interbody |
| M719SEC80709S0 | Stryker 9 mm AIS-C II Cervical-SA, Small, 3DP Convex Interbody |
| M719SEC80709L0 | Stryker 9 mm AIS-C II Cervical-SA, Large, 3DP Convex Interbody |
| M719SEC80708S0 | Stryker 8 mm AIS-C II Cervical-SA, Small, 3DP Convex Interbody |
| M719SEC80708L0 | Stryker 8 mm AIS-C II Cervical-SA, Large, 3DP Convex Interbody |
| M719SEC80707S0 | Stryker 7 mm AIS-C II Cervical-SA, Small, 3DP Convex Interbody |
| M719SEC80707L0 | Stryker 7 mm AIS-C II Cervical-SA, Large, 3DP Convex Interbody |
| M719SEC80706S0 | Stryker 6 mm AIS-C II Cervical-SA, Small, 3DP Convex Interbody |
| M719SEC80706L0 | Stryker 6 mm AIS-C II Cervical-SA, Large, 3DP Convex Interbody |
| M719SEC80612S0 | Stryker 12 mm AIS-C II Cervical-SA, Small, 3DP Parallel Interbody |
| M719SEC80612L0 | Stryker 12 mm AIS-C II Cervical-SA, Large, 3DP Parallel Interbody |
| M719SEC80611S0 | Stryker 11 mm AIS-C II Cervical-SA, Small, 3DP Parallel Interbody |
| M719SEC80611L0 | Stryker 11 mm AIS-C II Cervical-SA, Large, 3DP Parallel Interbody |
| M719SEC80610S0 | Stryker 10 mm AIS-C II Cervical-SA, Small, 3DP Parallel Interbody |
| M719SEC80610L0 | Stryker 10 mm AIS-C II Cervical-SA, Large, 3DP Parallel Interbody |
| M719SEC80609S0 | Stryker 9 mm AIS-C II Cervical-SA, Small, 3DP Parallel Interbody |
| M719SEC80609L0 | Stryker 9 mm AIS-C II Cervical-SA, Large, 3DP Parallel Interbody |
| M719SEC80608S0 | Stryker 8 mm AIS-C II Cervical-SA, Small, 3DP Parallel Interbody |
| M719SEC80608L0 | Stryker 8 mm AIS-C II Cervical-SA, Large, 3DP Parallel Interbody |
| M719SEC80607S0 | Stryker 7 mm AIS-C II Cervical-SA, Small, 3DP Parallel Interbody |
| M719SEC80607L0 | Stryker 7 mm AIS-C II Cervical-SA, Large, 3DP Parallel Interbody |
| M719SEC80606S0 | Stryker 6 mm AIS-C II Cervical-SA, Small, 3DP Parallel Interbody |
| M719SEC80606L0 | Stryker 6 mm AIS-C II Cervical-SA, Large, 3DP Parallel Interbody |
| M719SEC80605S0 | Stryker 5 mm AIS-C II Cervical-SA, Small, 3DP Parallel Interbody |
| M719SEC80605L0 | Stryker 5 mm AIS-C II Cervical-SA, Large, 3DP Parallel Interbody |
| M719SEC80512S0 | Stryker 12 mm AIS-C II Cervical-SA, Small, 3DP 10° Lordotic Interbody |
| M719SEC80512L0 | Stryker 12 mm AIS-C II Cervical-SA, Large, 3DP 10° Lordotic Interbody |
| M719SEC80511S0 | Stryker 11 mm AIS-C II Cervical-SA, Small, 3DP 10° Lordotic Interbody |
| M719SEC80511L0 | Stryker 11 mm AIS-C II Cervical-SA, Large, 3DP 10° Lordotic Interbody |
| M719SEC80510S0 | Stryker 10 mm AIS-C II Cervical-SA, Small, 3DP 10° Lordotic Interbody |
| M719SEC80510L0 | Stryker 10 mm AIS-C II Cervical-SA, Large, 3DP 10° Lordotic Interbody |
| M719SEC80509S0 | Stryker 9 mm AIS-C II Cervical-SA, Small, 3DP 10° Lordotic Interbody |
| M719SEC80509L0 | Stryker 9 mm AIS-C II Cervical-SA, Large, 3DP 10° Lordotic Interbody |
| M719SEC80508S0 | Stryker 8 mm AIS-C II Cervical-SA, Small, 3DP 10° Lordotic Interbody |
| M719SEC80508L0 | Stryker 8 mm AIS-C II Cervical-SA, Large, 3DP 10° Lordotic Interbody |
| M719SEC80507S0 | Stryker 7 mm AIS-C II Cervical-SA, Small, 3DP 10° Lordotic Interbody |
| M719SEC80507L0 | Stryker 7 mm AIS-C II Cervical-SA, Large, 3DP 10° Lordotic Interbody |
| M719SEC80506S0 | Stryker 6 mm AIS-C II Cervical-SA, Small, 3DP 10° Lordotic Interbody |
| M719SEC80506L0 | Stryker 6 mm AIS-C II Cervical-SA, Large, 3DP 10° Lordotic Interbody |
| M719SEC80505S0 | Stryker 5 mm AIS-C II Cervical-SA, Small, 3DP 10° Lordotic Interbody |
| M719SEC80505L0 | Stryker 5 mm AIS-C II Cervical-SA, Large, 3DP 10° Lordotic Interbody |
| M719SEC80412S0 | Stryker 12 mm AIS-C II Cervical-SA, Small, 3DP 7° Lordotic Interbody |
| M719SEC80412L0 | Stryker 12 mm AIS-C II Cervical-SA, Large, 3DP 7° Lordotic Interbody |
| M719SEC80411S0 | Stryker 11 mm AIS-C II Cervical-SA, Small, 3DP 7° Lordotic Interbody |
| M719SEC80411L0 | Stryker 11 mm AIS-C II Cervical-SA, Large, 3DP 7° Lordotic Interbody |
| M719SEC80410S0 | Stryker 10 mm AIS-C II Cervical-SA, Small, 3DP 7° Lordotic Interbody |