Atlas Spine Expandable Cervical Interbody System— 510(k) K180675
Substantially EquivalentAtlas Spine, Inc.
FDA 510(k) clearance K180675 for Atlas Spine Expandable Cervical Interbody System, Substantially Equivalent on 2018-06-13. Applicant: Atlas Spine, Inc.. Device class: 2.
Clearance details
- Applicant
- Atlas Spine, Inc.
- Product code
- Code ODP
- 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 ODP
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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 ODP
product code ODP- Injury
- 310
- Total
- 310
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.