| Primary Device ID | M719ACC80211S0 |
| NIH Device Record Key | 052c4ac8-b340-41d8-8c22-2efad637b349 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Stasys-C Standalone PEEK |
| Version Model Number | 1 |
| Catalog Number | ACC802-11S |
| 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 | 5123817089 |
| info@genesysspine.com | |
| Phone | 5123817089 |
| info@genesysspine.com | |
| Phone | 5123817089 |
| info@genesysspine.com | |
| Phone | 5123817089 |
| info@genesysspine.com | |
| Phone | 5123817089 |
| info@genesysspine.com | |
| Phone | 5123817089 |
| info@genesysspine.com | |
| Phone | 5123817089 |
| info@genesysspine.com | |
| Phone | 5123817089 |
| info@genesysspine.com | |
| Phone | 5123817089 |
| info@genesysspine.com | |
| Phone | 5123817089 |
| info@genesysspine.com | |
| Phone | 5123817089 |
| info@genesysspine.com | |
| Phone | 5123817089 |
| info@genesysspine.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M719ACC80211S0 [Primary] |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M719ACC80211S0]
Moist Heat or Steam Sterilization
[M719ACC80211S0]
Moist Heat or Steam Sterilization
[M719ACC80211S0]
Moist Heat or Steam Sterilization
[M719ACC80211S0]
Moist Heat or Steam Sterilization
[M719ACC80211S0]
Moist Heat or Steam Sterilization
[M719ACC80211S0]
Moist Heat or Steam Sterilization
[M719ACC80211S0]
Moist Heat or Steam Sterilization
[M719ACC80211S0]
Moist Heat or Steam Sterilization
[M719ACC80211S0]
Moist Heat or Steam Sterilization
[M719ACC80211S0]
Moist Heat or Steam Sterilization
[M719ACC80211S0]
Moist Heat or Steam Sterilization
[M719ACC80211S0]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-08-27 |
| Device Publish Date | 2025-08-19 |
| M719ACC830XXL0 | AIS-C II Cervical SA Anchor - Extra Extra Large |
| M719ACC830XL0 | AIS-C II Cervical SA Anchor - Extra Large |
| M719ACC830SM0 | AIS-C II Cervical SA Anchor - Small |
| M719ACC830MD0 | AIS-C II Cervical SA Anchor - Medium |
| M719ACC830LG0 | AIS-C II Cervical SA Anchors - Large |
| M719ACC1090 | AIS-C II Anchor Finisher Punch |
| M719ACC1080 | AIS-C II Cage Only Inserter |
| M719ACC1070 | AIS-C II Anchor Finisher |
| M719ACC80005S0 | 5mm AIS-C II CERVICAL STANDALONE, SMALL, PEEK PARALLEL INTERBODY |
| M719ACC80312S0 | 12mm AIS-C II Cervical Standalone, Small, Convex PEEK Interbody |
| M719ACC80312L0 | 12mm AIS-C II Cervical Standalone, Large, Convex PEEK Interbody |
| M719ACC80311S0 | 11mm AIS-C II Cervical Standalone, Small, Convex PEEK Interbody |
| M719ACC80311L0 | 11mm AIS-C II Cervical Standalone, Large, Convex PEEK Interbody |
| M719ACC80310S0 | 10mm AIS-C II Cervical Standalone, Small, Convex PEEK Interbody |
| M719ACC80310L0 | 10mm AIS-C II Standalone Cervical, Large, Convex PEEK Interbody |
| M719ACC80309S0 | 9mm AIS-C II Cervical Standalone, Small, Convex PEEK Interbody |
| M719ACC80309L0 | 9mm AIS-C II Cervical Standalone, Large, Convex PEEK Interbody |
| M719ACC80308S0 | 8mm AIS-C Cervical Standalone, Small, Convex PEEK Interbody |
| M719ACC80308L0 | 8mm AIS-C II Cervical Standalone, Large, Convex PEEK Interbody |
| M719ACC80307S0 | 7mm AIS-C II Cervical Standalone, Small, Convex PEEK Interbody |
| M719ACC80307L0 | 7mm AIS-C II Cervical Standalone, Large, Convex PEEK Interbody |
| M719ACC80306S0 | 6mm AIS-C II Cervical Standalone, Small, Convex PEEK Interbody |
| M719ACC80306L0 | 6mm AIS-C II Cervical Standalone, Large, Convex PEEK Interbody |
| M719ACC80212S0 | 12mm AIS-C II Cervical Standalone, Small, 10deg Lordotic PEEK Interbody |
| M719ACC80212L0 | 12mm AIS-C II Cervical Standalone, Large, 10deg Lordotic PEEK Interbody |
| M719ACC80211S0 | 11mm AIS-C II Cervical Standalone, Small, 10deg Lordotic PEEK Interbody |
| M719ACC80211L0 | 11mm AIS-C II Cervical Standalone, Large, 10deg Lordotic PEEK Interbody |
| M719ACC80210S0 | 10mm AIS-C II Cervical Standalone, Small, 10deg Lordotic PEEK Interbody |
| M719ACC80210L0 | 10mm AIS-C II Cervical Standalone, Large, 10deg Lordotic PEEK Interbody |
| M719ACC80209S0 | 9mm AIS-C II Cervical Standalone, Small, 10deg Lordotic PEEK Interbody |
| M719ACC80209L0 | 9mm AIS-C II Cervical Standalone, Large, 10deg Lordotic PEEK Interbody |
| M719ACC80208S0 | 8mm AIS-C II Cervical Standalone, Small, 10deg Lordotic PEEK Interbody |
| M719ACC80208L0 | 8mm AIS-C II Cervical Standalone, Large, 10deg Lordotic PEEK Interbody |
| M719ACC80207S0 | 7mm AIS-C II Cervical Standalone, Small, 10deg Lordotic PEEK Interbody |
| M719ACC80207L0 | 7mm AIS-C II Cervical Standalone, Large, 10deg Lordotic PEEK Interbody |
| M719ACC80206S0 | 6mm AIS-C II Cervical Standalone, Small, 10deg Lordotic PEEK Interbody |
| M719ACC80206L0 | 6mm AIS-C II Cervical Standalone, Large, 10deg Lordotic PEEK Interbody |
| M719ACC80205S0 | 5mm AIS-C II Cervical Standalone, Small, 10deg Lordotic PEEK Interbody |
| M719ACC80205L0 | 5mm AIS-C II Cervical Standalone, Large, 10deg Lordotic PEEK Interbody |
| M719ACC80112S0 | 12mm AIS-C II Cervical Standalone, Small, 7deg Lordotic PEEK Interbody |
| M719ACC80112L0 | 12mm AIS-C II Cervical Standalone, Large, 7deg Lordotic PEEK Interbody |
| M719ACC80111S0 | 11mm AIS-C II Cervical Standalone, Small, 7deg Lordotic PEEK Interbody |
| M719ACC80111L0 | 11mm AIS-C II Cervical Standalone, Large, 7deg Lordotic PEEK Interbody |
| M719ACC80110S0 | 10mm AIS-C II Cervical Standalone, Small, 7deg Lordotic PEEK Interbody |
| M719ACC80110L0 | 10mm AIS-C Cervical Standalone, Large, 7deg Lordotic PEEK Interbody |
| M719ACC80109S0 | 9mm AIS-C II Cervical Standalone, Small, 7deg Lordotic PEEK Interbody |
| M719ACC80109L0 | 9mm AIS-C II Cervical Standalone, Large, 7deg Lordotic PEEK Interbody |
| M719ACC80108S0 | 8mm AIS-C II Cervical Standalone, Small, 7deg Lordotic PEEK Interbody |
| M719ACC80108L0 | 8mm AIS-C II Cervical Standalone, Large, 7deg Lordotic PEEK Interbody |
| M719ACC80107S0 | 7mm AIS-C II Cervical Standalone, Small, 7deg Lordotic PEEK Interbody |