Atlas Spine Rebar (Ti) Spacer System— 510(k) K202302
Substantially EquivalentAtlas Spine, Inc.
FDA 510(k) clearance K202302 for Atlas Spine Rebar (Ti) Spacer System, Substantially Equivalent on 2020-10-30. 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
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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.