OIC Cervical PEEK Spacer— 510(k) K160222
Substantially EquivalentThe Orthopaedic Implant Company
FDA 510(k) clearance K160222 for OIC Cervical PEEK Spacer, Substantially Equivalent on 2016-12-07. Applicant: The Orthopaedic Implant Company.
Clearance details
- Applicant
- The Orthopaedic Implant Company
- Product code
- Code ODP
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Reno, NV, US
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.