Atlas Spine Expandable Cervical Standalone Interbody System— 510(k) K192570
Substantially EquivalentAtlas Spine, Inc.
FDA 510(k) clearance K192570 for Atlas Spine Expandable Cervical Standalone Interbody System, Substantially Equivalent on 2020-02-28. Applicant: Atlas Spine, Inc.. Device class: 2.
Clearance details
- Applicant
- Atlas Spine, Inc.
- Product code
- Code OVE
- Device class
- Class 2
- Regulation
- 21 CFR 888.3080
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jupiter, FL, US
Recent devices under product code OVE
view allMore clearances from Atlas Spine, Inc.
view all- K252822 — Atlas Spine HiRISE Expandable Cervical-p Corpectomy Implant
- K252560 — Atlas Spine HiRISE Expandable Cervical Corpectomy System
- K251969 — Atlas Spine Project X Expandable Posterior Lumbar Interbody System
- K243191 — Atlas Spine Lateral Expandable Interbody System
- K202302 — Atlas Spine Rebar (Ti) Spacer System
Adverse events under product code OVE
product code OVE- Injury
- 293
- Malfunction
- 710
- Total
- 1,003
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.